laser & light therapy - day spa association

CE Activity provided by:

National Coalition of Estheticians, Manufacturers/Distributors & Associations (NCEA)

LASER & LIGHT THERAPY

I N S T R U C T I O N S

1. To reinforce your learning and retain the information, highlight or underlinethe answers to each of the (30) Study Objectives.

2. Take the Three (3) Self-Assessment Tests, and then attach the tests to the CERegistration Form. Total test scores must be 75% or higher in order to obtain your CE Certificate.

3. Complete the CE Registration (Section A) and Course Evaluation (Section B).

4. Section C - Enclose a check or money order payable to NCEA:

N C E A Member Price: $ 4 4 . 9 5 Non Member Price: $ 6 4 . 9 5

5. Mail completed CE Registration Form, payment, & three tests to: N C E A CE Program, 484 Spring Avenue, Ridgewood, NJ 07450-4624.

G E N E R A L PURPOSE STATEMENT

To provide the skin care professional with a review of Laser & Light T h e r a p Y. The COA has approved this activity for 4 CEs and is good through July 1st, 2015.

LEARNING OBJECTIVES

After completing this interactive medical esthetics CE activity, the skin careprofessional will be able to:

1. Evaluate the role of the esthetician pre and post-procedures.

2. Describe laser & light therapy treatments for cosmetic and medical indications.

3. Understand scope of practice and increased safety responsibilities when performinglaser & light therapy procedures.

4. Summarize the history and physics of laser and light therapy.

Laser & Light Therapy - COA-Approved for 4 CEs 1©2011 NCEAAll rights reserved.

LASER & LIGHT THERAPY

Section A - CE Registration:

PRINT CLEARLY (Illegible forms will not be processed)

Name: ______________________________________________________________

Address: ____________________________________________________________

City: ___________________ State: ________ Zip: _____________ + ____________

Tel: _________________________________ Fax: ___________________________

Email: ______________________________________________________________ *Delivery Method used to send CE Certificate

Are you NCEA Certified? ___Yes___No If yes, NCEA Certified# _________________

License# ________________________ State of Issue _____________________

Type of License:

Esthetician ___ Cosmetologist ___ Teacher ___ Medical Professional ___

Other ___ Please specify: ______________________________________

Section B - Course Evaluation:1. Did this CE activity's learning objective relate to its general purpose? ___Yes ___No

2. Was the interactive format an effective way to present this material? ___Yes ___No

3. Was the content relevant to your skin care practice? ___Yes ___No

4. What type of setting do you currently work in? ___________________________________

5. How long in minutes did it take you to read the article_______, study the material_______,

and take the self-assessment tests_______?

6. Suggestions for future topics__________________________________________________

___________________________________________________________________________

Section C - Payments and Discounts:The fee for this CE Activity for NCEA Members: 44.95 Non Members: $64.95

(Check or money order payable to NCEA)

*We offer special discounts for 6 or more CE Activities that are for institutional use..

Call (201) 670-4100 Ext 5, for visit www.NCEA.tv more information.


Laser & Light Therapy

Lea registered to attend an upcoming NCEA42 hour laser light therapy course and sheshared her exuberance with Anna, one of hercolleagues at work. “You're wasting yourmoney taking the class, physics is boring. Justget hands-on experience, that’s all you need,”exclaimed Anna.

Lea was concerned for the safety of Anna’spatients because Anna had received only fourhours of training from the manufacturer of thedevice. On one occasion, Anna had to perform atreatment on a client who came from multi-cultural background. She hoped her settingswere correct so that the client would obtaingood results. Sometimes in the rush of the daythough, she failed to properly document hertreatments. For all these reasons, at lunch timeLea took the time and sat down with Anna toshow her the class curriculum outline.

“Wow!” exclaimed Anna. “Are you sureyou will understand all of that?”

Lea shared with Anna that there was more tounderstanding light therapies than just doingthe hands-on treatment. After spending sometime one evening researching laser and lighttherapies, Lea concluded that there was more tolearn regarding their effectiveness and use inesthetics. Laser hair removal was only oneapplication of how lasers and light therapydevices can enhance the skin. The technology isvery advanced. It is imperative to learn how thedevice works in order to better serve the needsof my clients. By this time Anna became moreattentive.

“Did you know that LED light is used in thespace capsule to help astronauts heal wounds ina non-gravitational environment?

I also earned continuing education unitswatching a webinar on basic phototherapytheory and what differences are in light-basedmodalities. I even watched a webinar on federaland state issues that will affect a laser practice,“said Lea.

“Really?” exclaimed Anna. Lea continue to share with Anna the

importance of understanding the science of thebiological effects of lasers and light emittingdiodes, and their role in esthetic treatments.They can effectively be integrated as part of thenew, innovative approaches to skinmanagement programs. By gaining greaterinsights can only help her make better decisionsfor her clients, exclaimed Lea.

Lea continued to talk about some poor laserresults due to operator error. It was reallyscary. She did not want to operate a machinewithout more knowledge about safe operation.After all, it was important to be concernedabout client safety and good results.

And finally it was essential that she gainproper credentials and continue to attendadvanced education in this growing field.Additionally, networking with other NCEACertified Professionals and attending annualconferences supported her growth.

• What challenges do you think Anna mayincur during her treatments?

• Do you agree with Lea’s attitude towardsobtaining additional education?

• Can you think of a time when you were notsure of how to proceed with a procedure?


StudyObjectivesHighlight/underline theanswers to the followingquestions as you read:

1. Who developed thequantum theory?

2. What is in the centerof an atom?

3. What are 3 light-based modalities?

4. How are lasersdifferentiated?

5. What is the mostcommon laser usedtoday?

6. How can temporaloutput be described?

7. How do fractionatedlasers deliver energy?

8. What are threeprincipal parts oflaser construction?

9. What are 3characteristics of laserlight?

10. List thechromophores tissuereaction andabsorption?


History

Lasers re p resent a form of energy that can be manipulatedto accomplish a number of medical pro c e d u res from thecomplex surgical removal of an acoustic neuroma in anoperating room(OR) to the less invasive removal ofunwanted body hair or facial rejuvenation in a salon or spa.R e g a rdless of the pro c e d u re, it is important to understandthe properties and safety aspects of laser utilization. Thisknowledge will enable you to manage a safe and successfullaser and light therapy practice.

In 1917, Albert Einstein proposed the concept for thetheory of stimulated emission of radiation. Lasers haveexisted in medicine since the early 60's when TheodoreMaiman developed the first working laser using a crystal ofruby, based on Shawlow and Townes theories. Advancing thequantum theory developed by Albert Einstein, this laserwas soon followed by a C02 gas laser invented in 1964 byKumar Patel, PhD. Leon Goldman, M.D., often referred to asthe Father of Lasers in Medicine, founded the American Societyfor Laser Medicine and Surgery.

Envision a tiny solar system with revolving planetsaround a central sun. This system can represent the atom ormolecule. At the center of the atom, is the nucleus thatcontains protons and neutrons, with a balanced number ofelectrons circling around the center. In order for laser lightto occur, additional energy must be added (stimulated).This added energy can come from electricity or anothersmall laser for example. After the electrons are stimulatedby this added energy, they shift or bump out of theirnormal orbit. The electron wants to stay in the system. Tostabilize itself, the electron gives off a photon beforereturning to its normal orbit. This released photon, or unitof light energy, travels within the laser housing and strikesother like molecules stimulating the emission of more andmore photons. Soon this avalanche effect of photons iscaptured as laser light. As this light strikes biologic tissue,light energy is transformed into heat energy to create adesired effect.

Laser & Light Applications

Many different types of lasers and light therapies have

since emerged utilizing different mediumsof gases, solids, liquids and semiconductors. These laser mediums all havedifferent wavelengths and thereforedifferent effects on human tissue. Light therapies have numerousapplications. Light based modalities are

• Laser Light• Intense Pulsed Light• Non-laser Light Emitting Diodes (LED)

They can be used many ways including1. Ophthalmogy: cornea repair or

correction; retina repair.2. Dermatology: removal of skin tumors,

external ulcers, and warts, removal oftattoos, treatment of port wine stain,hemangiomas.

3. Esthetics/Cosmetic: hair reduction,skin rejuvenation.

4. Oncology: Tumor ablation.5. Photodynamic therapy: photochemical.

Definition of LaserThe word LASER is an acronym that

describes the physics of how laser light isgenerated.

It stands for "Light Amplification by theStimulated Emission of Radiation". A laseris a device that uses a quantum mechanicaleffect, stimulated emission, to deliver acoherent beam of light from the lasingmedium.

There are two types of lasers: ablativeand non-ablative. Lasers, however, arefurther classified into subcategories withnumerous variations. The main differencesbetween laser types are their wavelength.Additionally, depending upon theirwavelength, surgical lasers and cosmeticlasers have different degrees ofinvasiveness.

Ablative (Cutting)

Irradiation of cancer cells; optical(ophthalmology); surgical, skin resurfacing.Cutting lasers remove warts, skin tags, andare used to assist surgical procedures forcutting skin.

• C02 (gas laser)• Erbium YAG (infrared 2940 nm)

Non-ablative (Aesthetic/Cosmetic)

Hair removal, laser skin rejuvenation,vascular (telangiectasias) treatment,pigmentation reduction).

• Nd:YAG (Continuous or Q-switched 1064 nm )

• Alexandrite (755 nm)• Pulsed Dye (577-585nm)• Diode laser (810 nm)

1. Lasers are differentiated by theirwavelengths, and active medium whichcan be a solid, liquid, gas or diode.

Solid StateThe term “solid-state,” as related tolasers, refers to a laser that uses acrystal as the lasing medium. Thiscrystal has an impurity called a“dopant.” It is the “dopant” withinthe crystal that determines thewavelength of the laser emission.Solid State does not includesemiconductor materials used inlaser diodes. An example of a solidstate laser is a Ruby laser which usesa ruby crystal as the lasing medium.Nd:YAG, Alexandrite, and Erbiumalso have crystals as the lasingmedium. Most cosmetic (aesthetic)lasers are solid state. They can beoperated as a continuous wave (CW)or pulse mode.


Liquid

The common liquid lasers utilize aflowing dye as the active medium,and are pumped by a flash lamp orby another laser, such as an argonlaser. These are typically rathercomplex systems, requiring moremaintenance. They may be operatedeither CW or pulsed, and have theadvantage that they are wavelengthtunable, perhaps over a 100 nmrange. An example is the flashlamp-pumped dye laser operatingbetween 585 nm through 600 nm.This laser is used for port wine stain,telangiectasia, warts andhypertrophic scars.

Gas

Gas lasers are not unlike fluore s c e n tlight bulbs and neon signs. In thehelium-neon (HeNe) laser, a mixtureof helium and neon gas is confined toa hollow glass tube. As in the neonsign, an electric current passingt h rough the tube excites the atomsand causes them to emit light. In theHeNe laser, mirrors at the ends of thetube form a resonant cavity whichhelps create and aplifiy the laserbeam. Gas laser systems include C02,A rgon (Ar), Xenon-Chloride. Theymostly operate as a continuous wave(cw) mode but can be used in arepetitively pulsed mode.

Diode (Semiconductor)

In terms of sheer numbers, the diodelaser is the most common lasertoday. The two common families of

diode lasers are composed ofGaAlAs,(Gallium/Aluminum/Arsenide), with output wavelengths inthe 750-950 nm range, and InGaAsP(Indium/Phosphorus), whosewavelength is in the 1100-1650 nmrange. The former group iscommonly used in compact audiodisk, CD ROM, and laser printertechnology, while the latter formsthe basis of modern opticaltelecommunications. Diode lasersused in aesthetic applicationsoperate at 810 nm and 980 nm. The810 diode is used for hair removaland the 980 nm is used fortreatment of vascular lesions andtelangiectasia.

2. Temporal Output of a laser can bedescribed as Continuous Wave (CW), orPulsed.

Continuous wave (CW)

These emit a continuous beam andinclude the C02 and Krypton lasersused for coagulating tissue (moles,warts), pseudo-continuous wavelasers emit a beam in such closepulses that the tissue effect is thesame as a continuous wave laser.

Pulsed

The beam of energy is emitted invery short pulses normallyseparated by 0.1-1 second. Pulsedlasers are very selective in theirdestructive effect. They are used inselective photothermolysis such ashair removal lasers.


Q-switched lasers are pulsed lasersthat produce high peak powers byuse of a device called a quality switch.This device produces very shortintense laser pulses by an electricd i s c h a rge that is pulsed in and out ofthe lasing medium. Energy is store din the laser cavity then released in onesingle, short and very powerful pulse.The pulse duration is from 10 ns to250 ns. Power outputs are in themegawatt to gigawatt range (asopposed to milliwatt). They allow formechanical destruction of a targ e tinstead of thermal. Q-switched lasersa re used in tattoo, some pigment andbirthmark re m o v a l .

Fractional

Older C02 lasers involvedvaporization of the epidermis andupper dermis during facialresurfacing. Fractional lasers delivere n e rgy in a limited way meaning thatthey split the laser light intothousands of microscopic columns ofheat. Fractional pulses are termed asm i c rothermal zones (MTZ). Thro u g ha process of fractionalphotothermolysis, targeted cellswithin theses columns are destro y e dleaving the surrounding tissue intact.Fractional lasers can be used in anablative or non-ablative mode. Theya re used to treat cosmetic issues suchas acne scars, stretch marks, aging,and sun damaged skin.

Physics

In order understand the workings of alaser it is important to review the

understanding of atoms and electro n s .Atoms are what make up all matter. In aresting stage (zero stage), the electrons ro t a t ea round the nucleus and the atom is at itslowest state of energ y. This “ground statee n e rgy” can soon change with thei n t roduction of an energy source. Theorbiting electrons can be moved to a higherstate of excitement. When the energy sourc eis removed, and the atom returns to itsnormal state (resting state), it releases aphoton in the process (spontaneous emissionof radiation). Photons stimulate other excitedatoms in the active medium to re l e a s eadditional photons, causing a chain re a c t i o n .When the number of excited atoms exceedsthe number of non-excited atoms, the energ yis amplified which creates the laser action.Inside the tube this cascade of excited atomsreleasing photons generates the laser beam.

Laser Construction

Lasers are constructed based on threeprincipal parts: An energy source (usuallyreferred to as to the pump or pumpsource), a gain medium or laser medium, andtwo or more parallel mirrors that form anoptical resonator.

Pump Source (system)

This is the laser’s power supply requiredto stimulate the lasing medium. Powersource can include electricity or flash lampor radio frequency.

The Laser Medium

This is the substance that is stimulatedto produce the laser beam (gases: argon,C02, krypton, Helium-Neon), liquid (dye),or solid (solid crystalline materials: ruby or


alexandrite crystals. This mediumdetermines the wavelength of energy.

Optical Resonator

This is the actual “cavity” or “tube” thatencloses the lasing medium that is excitedby the power source. This cavity consists ofspecially designed reflective mirrorsopposite each other. One mirror is highlyreflective, the other partially reflective. Thehighly reflectance mirror reflects 100% ofthe light which strikes it. The other mirrorreflects less than 100%. The small fractionof light which passes through the partiallyreflective mirror is the beam output, the“doorway” where the beam exits. It is thisbuildup or amplification of energy thatmakes the laser beam so powerful.

Characteristics of Laser Light

Laser light is collimated, coherent, andmonochromatic.

Collimated

The laser rays are nearly parallel orcollinear. A beam of high energy lightfocuses precisely on the target. The lightdoes not disperse but remains tight.

Coherent

Coherence are wavelengths that are inphase with one and other. Thissynchronicity increases its brightness(amplification).

Monochromatic

Monochromatic light consists of onewavelength producing a pure color.

Energy Measurement and Delivery

Energy from lasers is measured in Joules.Pulsed energy delivery is used in mostaesthetic lasers that tend to provide quick,short pulses into the tissue, e.g., hairremoval, skin rejuvenation, veins.

Single-pulsed lasers deliver in a slowerway such as found in ablative lasers.

A Joule is a unit of energy. It describesthe total amount of energy. For example,you may deliver 45 joules of energy in alaser pulse.

Fluence or Radiant Exposure is theamount of light energy delivered persurface area. The units of fluence are jouleper square centimeter.

Chromophores Tissue Reaction andAbsorption

Chromophores

Hair removal – melanin

Pigmented lesions – melanin

Vascular lesions – hemoglobin, dark protein

Skin rejuvenation – water, collagen, hemoglobin

Tattoo removal – dyeAcne - porphyrins

Biological tissue–specifically melanin,blood, and water–contain chromophoremolecules to which specific wavelengths oflight energy are absorbed. Differentmolecules absorb different wavelengths oflight. In other words, each chromophorehas a characteristic absorption spectrumand particular wavelengths of light that are


Self Assessment Exercise 1

1. Lasers

a) Function with filters

b) Are collimated

c) Deliver across a broad spectrum of wavelengths

d) All of the above

2. The energy of a laser occurs when:

a) The energy source is removed

b) Excited atoms exceeds the number of non-excited atoms

c) Photons are released from the tube

d) Photons stimulate other excited atoms

3. Laser mediums can be

a) Solid crystals

b) Gas or liquid

c) Rubys

d) All of the above.

4. Chromophore molecules

a) Attract specific wavelengths

b) Have a selective absorption spectrum

c) Are found in all biological tissues

d) All of the above

5. LASER stands for: ______________ ______________ ______________

______________ ______________


more selectively absorbed compared to other chromophoresat that wavelength.

Once a photon (light) is absorbed the energy istransformed into thermal, chemical or mechanical energy.The law of Grotthuss-Draper directs all laser light tissueinteraction – light must be absorbed to create an effect.

In laser hair removal, for example, the laser is attractedto the melanin in the hair shaft in the follicle. Wavelengthcould be anywhere from 755 nm – 1064 nm dependingupon the type of client. The laser must “see” the color inorder to damage the follicle so that the hair doesn’t growagain. There is no target in the absence of color, e.g., whiteor gray hair.

The type of laser (wavelength) to be used with hairreduction or with vascular or pigmented lesions is highlydependent upon the Fitzpatrick type of the skin. Forexample, certain wavelengths of energy have a greateraffinity for brown pigment. Selecting a wrong laserwavelength could burn a client with darker skin type.

Therapeutic Properties of Lasers

Thermal energy that destroys a target has variable effectson tissue.

1. Tissue Heating: e.g., Skin rejuvenation2. Rapid heating: Causes vaporization of tissue (thermal

destruction) e.g., C02 skin resurfacing.3. Incision or bulk ablation4. Extremely rapid heating such as demonstrated in a

Q-switch laser leads to the shattering or explosion of tissue.

Selective Photothermolysis and Thermal Relaxation Time

A key principle behind the success of the laser is aprocess known as selective photothermolysis. “Photo”means light, “thermo”= heat, and “lysis” means destruction.This process refers to the precise targeting of a structure oftissue using a specific wavelength of light. A target isdestroyed through a rapid heating without destroyingsurrounding tissue. Aesthetic lasers are designed and


11. What is the law ofGrothus-Draper?

12. What are fourtherapeutic propertiesof lasers?

13. What is selectivephotothermolysis?

14. What is thermalrelaxation time?

15. Who should establishlaser safety protocols?

16. What is the NominalHazard Zone?

17. Who is in charge ofthe laser room?

18. What is the LaserSafety Officerresponsible for?

19. Where do you findthe “Indications forUse” of a device?

20. What are the 4 LaserHazard Classes?

21. Who regulatesesthetician licensesand use of laser/lighttherapy devices?


engineered to perform precisely the goal ofthe treatment, avoiding injury tosurrounding tissue.

Thermal Relaxation Time (TRT)

Thermal relaxation time of a mass is thetime required for it to cool down to thenormal temperature of the surroundingarea after being heated. TRT is dependentupon the size and shape of the target.When the laser energy hits biologicaltissue, the generated heat must remainconfined in the target (thermal diffusion),long enough to destroy the target BEFOREthe heat defuses. In a hair follicle, thedamage of the hair bulb (bulge) must takeplace before the thermal relaxation time.

Depth of Penetration and Spot Size

Three variables control the depth ofpenetration; wavelength, spot size, andpower.Wavelength – the longer the wavelength,the deeper the penetration.

Spot size – the bigger the size the greater thed i v e rgence. A laser spot size is normally alittle larger than the target. It could be thesize of a pencil eraser. Depending upon thet a rget – e.g., hair follicle, vein, and collagen –the re q u i rement for the spot size is diff e re n t .

Irradiance - Technique is very critical to aneffective outcome. Hand movementsduring the lasering process are vital toresults and outcome.

Summary of Laser Effects

When laser light strikes tissue it can be– Transmitted

– Scattered – longer waves experience less; shorter more

– Reflected

– Absorbed – through selection

Dependent upon

– Type of tissue

– Wavelength (color nm)

– Fluence (intensity) amount of energydelivered per unit of surface area (J/cm2)

– Pulse width – time interval over which energy is delivered

– Diameter of beam (spot size) measure in mm

– Repetition rate – number of pulses/second (Hz)

– Cooling methods

What Is The Difference Between A Laserand Intense Pulsed Light (IPL)?

I P L systems are not lasers. Each deliverse n e rgy diff e re n t l y. Lasers deliver light in asingle wavelength targeting one specificc h ro m o p h o re. An IPL functions with filters.N o n - c h romatic (or poly-chromatic meaningmultiple diff e rent wavelengths) light isc reated by an energy source and thenf i l t e red. IPL light delivers energy across ab road spectrum of wavelengths (500-1200nm) through a pulse sequencing pro c e s s .Special cut-off filters are used to block outwavelengths of light. There are a range ofconditions that can be treated with an IPLdevice. There are multiplatform machinesthat have both laser and IPL devices right onthe unit allowing for great flexibility fort re a t m e n t .


The spot size for an IPL is larger than alaser. It delivers a bigger application ofenergy to the skin area. IPLs deliver energythrough a short burst of emitted light froma flash lamp for a specific condition. A laserand an IPL are two different sources ofenergy. They are not the same. IPLs areused for hair reduction, vascular lesions,and pigmentation as well as skinrejuvenation.

Radio Frequency

Radio frequency (RF) devices have avery low frequency represented in devicessuch as Thermage™ (Solta Medical, Inc.,Hayward, California). Radio frequencyproduces heat (thermal injury) deep withinthe dermis causing tissue tightening andremodeling. There is a controlled thermalheating of collagen fibers including thefibrous septae. There is a differencebetween Radio Frequency and lasers.Lasers convert light to heat and targetspecific superficial structures orchromophores through a process ofselective photothermolysis. RF producesheat to a greater volume of tissue when thetissue’s electrical resistance converts theelectric current to thermal energy deeper inthe dermis.

Light-Emitting Diodes (LEDs)

LEDs are neither a laser nor IPL.Through a process of thermolysis, Lasersand IPL selectively destroy a specific target.LED’s have a much lower energy outputand stimulate biological tissue bysupporting collagen synthesis, repair,circulation, support the reduction ofinflammation, and the appearance of some

pigment. LED’s do not destroy tissue. A light therapy unit functions with LED

diodes (not to be confused with a diodelaser). LEDs can emit pure wavelengthsbetween 400 nm and 700 nm (visible light).After 700 nm the energy moves out of thevisible range and into more heat producingthermal effects onto the skin.

Biological Effects of Various Wavelengths– LED

Blue Light 470 nm (visible spectrum)• Penetrates into follicle• Destroys acne-causing bacteria• Removes redness and irritation

Green Light 525 nm (visible spectrum)• Penetrates to dermal capillary beds• Decreases melanin production• Regulating and soothing effects

Yellow Light 590 nm (visible spectrum)• Absorbed by body fluids; effects

lymph and blood circulatory systems• Promotes wound healing• Reduces inflammation

Red Light 640 nm (visible spectrum)• Reduces inflammation • Absorbed by all tissues, specifically

in dermis• Possesses the most regenerative

properties


Laser Safety

Each laser and light facility regardless ofits size should establish and maintain anadequate safety program for the control oflaser hazards. The employer has thefundamental responsibility for assurance ofthe safe use of lasers owned and/oroperated by the employer or employee.

1.Signage, warning signs shall beconspicuously displayed on all doorsentering the treatment room. (NominalHazard Zone) Appropriate goggles needto be hung on the door. Sign needs to beremoved when laser is not in use.

2.Skin safety, protective measures includenon-flammable preps, shielding of tissue,availability of water, non-reflectiveinstrumentation, removal of reflectivejewelry.

3.Following infection control proceduresand using personal protective equipmentwhen working with bodily fluids, andlaser plumes.

4.Electrical safety, proper grounding andinsulation.

5.Fire safety, protective measures includefire extinguishers, wet drapes and fireblankets.

6.Laser generated airborne contaminate(LGAC) use of high flow smokeevacuators and vacuum filters. Gasesfrom laser procedures needs to beremoved with smoke evacuator systems.

7.All equipment must be maintainedaccording the directions from themanufacturer. Most laser companies DONOT allow laser operation personnel toopen a machine for maintenance. Thismust be done by a certified companytechnician.

8.Non-laser personnel should not be in the


area of treatment.9.The person operating the laser is in full

charge of the laser room and assistingpersonnel during the actual laseroperation.

1 0 .Safety policies and procedures need tobe established and copies kept posted.They should include authorizations forlaser use, operating instructions, prior-to-use checklists, and maintenance/servicei n s t ructions.

11.Many lasers are computer based with‘smart’ features, so that they willperform a number of these stepsincluding calibration, safety checks andother parameter tests upon startup andcan notify the user of equipmentproblems.

12.Newer lasers often come withsophisticated built-in safety features suchas protective housings around the laser,interlocks on the protective housings, akey control and warning systems.Nevertheless, to prevent unauthorizedoperations your laser needs to be eithers e c u rely stored when not in use orre q u i re a key or coded access to enablethe laser.

Other safety features include:

13.The switch or a stand by mode whichc o n t rols client exposure must be guard e dto prevent inadvertent activation. A n o t h e rway to accomplish this is to re q u i re twosimultaneous actions, such as foot pedald e p ression and hand trigger, in order too p e r a t e .

14.An emergency shutoff switch must beavailable to the operator or assistant toenable the rapid shutdown ofequipment.

15.Equipment must be serviced andmaintained as recommended bymanufacturer to ensure safeguardsremain functional.

16.The laser operator should periodicallycheck electrical cords for damage.

17.Check any skin coolant hoses supplied,for wear and any damage.

18. The laser key must not be left in themachine. It should be stored in a safeplace.

19.All testing of the laser should be donebefore the client enters room by staff thatis adequately protected.

LASER SAFETY OFFICER

The management organization mustdesignate a Laser Safety Officer (LSO) forthe facility, to be responsible forimplementing a laser safety program for allcircumstances where there is human accessto Class 3B* and/or class 4 levels of laserradiation. *According to the AmericanNational Standards Institute (ANSI) Z136.1The laser safety officer is responsible for:1.Establishing the laser treatment

controlled area.2.Approving standard operating

procedures (SOPs), administrative andprocedural controls.

3. Ocular safety, protective eyewear ismandatory and shall be marked with theappropriate wavelength and opticaldensity.

4.Auditing the functionality of controlmeasures periodically to ensure properoperation.

5.Approving the wording on area signsand equipment labels.

6.Assuring adequate safety education andtraining are provided to laser areapersonnel.

7.Determining the personnel categories (i.e.laser personnel or incidental personnel)for medical surveillance.

8.Laser personnel are those who workroutinely in the laser environment andmust be fully protected. It should besupervised and occupied only by trainedstaff or other authorized persons who aresufficiently protected. Protective eyewear must be worn at all times duringlaser operation by both the patient andpersonnel.

9.Incidental personnel are those whosework makes it possible but unlikely thatthey will be exposed to laser energysufficient to damage their skin or eyes.For example clerical and/or supervisorypersonnel of staff who do not workdirectly with lasers.

10.Large facilities having an owner(s),employer and several employees, maydesignate a laser safety officer and givehim/her the authority he/she needs tocarry out their responsibilities. In smallerfacilities however, the owner may also bethe laser safety officer.

In all cases a laser safety officer must bedesignated and must have authority tocarry out a laser safety program in thefacility. This individual must have thenecessary training and experience toadminister a laser safety program. He/shemust be authorized by the employer and beresponsible for monitoring and overseeingthe control of laser hazards.


FDA Device Classification

FDA's Center for Devices andRadiological Health (CDRH) is responsiblefor regulating firms who manufacture,repackage, relabel, and/or import medicaldevices sold in the United States. Inaddition, CDRH regulates radiation-emitting electronic products (medical andnon-medical) such as lasers, x-ray systems,ultrasound equipment, microwave ovensand color televisions.

* Radiation-emitting Electronic Products

Medical devices are classified into ClassI, II, and III. Regulatory control increasesfrom Class I to Class III. The deviceclassification regulation defines theregulatory requirements for a generaldevice type. Most Class I devices areexempt from Premarket Notification 510(k);most Class II devices require PremarketNotification 510(k); and most Class IIIdevices require Premarket Approval.

The Food and Drug Administration,Department of Health and HumanServices, oversees the regulation of devicesfor safety and effectiveness, as well asmany other responsibilities, which are notcovered here.

The FDA has established classificationsfor approximately 1,700 different generictypes of devices and grouped them into 16medical specialties referred to as panels.Each of these generic types of devices isassigned to one of three regulatory classesbased on the level of control necessary toassure the safety and effectiveness of thedevice. Section 510(k) of the Act requires aperson who wishes to introduce a device

into commerce to notify the Center at leastninety days in advance. This premarketnotification is referred to as a "510(k)." TheAgency uses 510(k)s to determine if newdevices are, or are not, substantiallyequivalent to another device alreadycleared to market.

Device Class and Regulatory Controls

1. Class I General Controls

• With Exemptions

• Without Exemptions

2. Class II General Controls andSpecial Controls

• With Exemptions

• Without Exemptions

3. Class III General Controls and • Premarket Approval

These standards are met by themanufacturer of the device and submittedto the FDA in the form of a 510(k)Summary of Safety and Effectiveness. Thedevice’s summary includes the submitter’sinformation, device information, predicatedevices, intended use, device description,performance and clinical data, andsubstantial equivalence. Upon review bythe FDA, the device may be given approvalto go to market, subject to the generalcontrol provisions of the Federal Food,Drug and Cosmetic Act. These provisionsinclude requirements for annualregistration, listing of the device, goodmanufacturing practice, labeling, andprohibitions against misbranding andadulteration.


Laser and light therapy devices fallunder the classification name: Lasersurgical instrument for use in general andplastic surgery and and dermatology(21CRF 878.4810)

Device classification depends on theintended use of the device and also uponindications for use.

The Meaning of Intended Use

While a new device must have the same‘intended use’ as a predicate device inorder to be substantially equivalent(SE), theFDA does not require that the new devicebe labeled the same. Label statements mayvary. Certain elements of a predicatedevice's labeled indication may not becritical to its intended therapeutic,diagnostic, prosthetic, surgical, etc., use.The Center's scientific expertise enables itto exercise considerable discretion ininterpreting ‘intended uses’ in the labelingand promotional materials for predicateand new devices. Thus, a new device withthe same intended use as a predicate devicemay have different specific indicationstatements, and, as long as these labelindications do not introduce questionsabout safety or effectiveness different fromthose that were posed by the predicatedevice's intended use, the new device maybe found SE. However, many havemisinterpreted to mean that these devicesare for medical use only–which is incorrect.

For the purposes of determiningwhether or not the new device has thesame intended use as a predicate device,the Center assesses any difference in labelindications in terms of the safety andeffectiveness questions they may arise. TheCenter considers such points as

physiological purpose (e.g. removes waterfrom blood, transports blood, cuts tissue),condition or disease to be treated ordiagnosed, professional or lay use, parts ofthe body or types of tissue involved,frequency of use, etc. If a new device isdetermined to have the same ‘intendeduse’, the Center may then proceed todetermine whether or not it is substantiallyequivalent. (Devices which do not have thesame intended use cannot be substantiallyequivalent.)

The classification system is a way tocategorize like devices and allow marketingof devices when substantial equivalentdevices have already received approval. Inaddition, classification is risk based, that is,the risk the device poses to the patientand/or the user is a major factor in theclass it is assigned. Class I includes deviceswith the lowest risk and Class III includesthose with the greatest risk.

As indicated above all classes of devicesas subject to General Controls. GeneralControls are the baseline requirements ofthe Food, Drug and Cosmetic (FD&C) Actthat apply to all medical devices, Class I, II,and III.

There are currently five laser lightdevices that have been cleared forconsumer use:

a) Flash N’Go (Home Skinnovations, Ltd.)(K082298)- Light based hair removal device- Class II, Over The Counter Use

b) ABC Hair Removal System, (PalomarMedical Technologies, Inc. (K060839)Light Based Hair Removal SystemClass II, Over the Counter Use

c) SpaTouch® PhotoEpilation System,(Radiancy Ltd.) (K020856)


Pulsed Light Hair Removal SystemClass II, Prescription Use

d) Silk’n , (Home Skinnovations, Ltd.)(K072906)- Light based hair removal device- Class II, Prescription Use

e) Spectra Hair Removal Laser System,(SpectraGenics, Inc.)- Pulsed Diode LaserClass II, Over the Counter Use

f)TRIA Laser Hair Removal System (TRIABeauty, Inc. (K090820)

- Pulsed diode laser- Class II, Over the Counter Use

Laser Hazard Classes

The Food and Drug Administration(FDA) also recognizes four major hazardclasses (I to IV) of lasers, including threesubclasses (IIa, IIIa, and IIIb). The classesare based upon a scheme of graded risk.They are based upon the ability of a beamto cause biological damage to the eye orskin. In the Federal Laser ProductPerformance Standard (FLPPS), the classesare established relative to the AccessibleEmission Limits (AEL) provided in tablesin the standard. In the American NationalStandards Institute (ANSI) specifically theANSI Z 136.1 standard, the AEL is definedas the product of the Maximum PermissibleExposure (MPE) level and the area of thelimiting aperture. The higher the class themore hazardous the laser. The labeling forClasses II -IV must include a warningsymbol that states the class and the outputpower of the product.

State Regulatory Board Oversight

It is up to each state regulatory boardthat oversees licensees to determine who

can use laser and light therapy devices.Some states have limited use of lasers andlight therapy to physicians only. Yet otherstates allow estheticians who are undermedical supervision to use them, and a fewstates have now included laser and lighttherapy training in the estheticiancurriculum. Some states are now requiringcertification or credentialing that include amandatory number of hours of trainingprior to operating a laser. Anyoneoperating a laser or light therapy deviceshould be thoroughly educated, trainedand/or certified and understand thephysics and biological effects.

Medical Supervision & CorporatePractice of Medicine

Many states have not yet defined‘medical supervision’ in their statutes orrules. The interpretation of medicalsupervision can mean anything from aphysician available by telephone to beingphysically in the same office.

If ‘medical supervision’ becomes a staterequirement for use of laser and lighttherapy devices, it could mean that theesthetician would more than likely, have tobecome an employee of the physician.

The corporate practice of medicine is alegal doctrine, which generally prohibitscorporations, entities or individuals frompracticing medicine. This would alsoprohibit lay entities (estheticians,salons/spas, etc) from hiring a physician towork as a medical director or provide‘medical supervision.’

The advice of a health attorney toexplore these legal issues in your state isrecommended prior to purchase of a laseror light therapy device.



NCEA’s Equipment Evaluation Form

Equipment Identification and InformationName of equipment:

Type of equipment:

Model number:

Price:

What is the manufacturers‘ Intended Use Statement’?

Company profile information:

Sales Contact Information:Name:

Address:

City: State: Zip:

Tel:

Fax:

Email:

Website:

Length of time in business:

Distributor Contact Information:Name:

Address:

City: State: Zip:

Tel:

Fax:

Email:

Website:

Length of time in business:

Registrations/Certifications

Is the manufacturer registered with the FDA?

If yes, what is the registration number?

Is the equipment registered with the FDA?

If yes, what is the registration number and class?

Is the device registered with the state, if required?

Safety Considerations and Equipment Specifications

What safety certifications does this equipment have (i.e. UL, CSA, CE)?

What kind of power source does the equipment require?

Does the manufacturer carry liability insurance on this equipment?

Is a certificate of insurance available?

Does the equipment have any cross-contamination safeguards, if applicable?

What are the contraindications for use of this equipment?

If purchasing a used device,

a) What was the date of the last preventative maintenance?

b) Is the preventative maintenance report available?

Warranty and Service Policies

What are the terms of the warranty?

Is there an extended warranty available?

Is there an additional cost?

Do you have an equipment loaner program?

Are references available?

Training and Education

What type of training is included with purchase?

Where? Total hours?

Who are the educators?

Is there an additional cost?

Skin care professionals are required to check in their state as to whether training on the use ofequipment is required prior to purchasing, and/or if they can use device under their scope ofpractice.



1. The bigger the size the greater the __________________.

2. What is the effect of the laser dependent upon?

a) Pulse width

b) Type of tissues

c) Diameter of beam

d) All of the above

3. List two biological effects for each of the the following wavelengths:

Blue light ______________________________________________________

______________________________________________________

Green light ______________________________________________________

______________________________________________________

Yellow light ______________________________________________________

______________________________________________________

Red light ______________________________________________________

______________________________________________________

4. FDA’s Laser Hazard Classifications are based upon:

a) Ability of a beam to cause biological ocular or skin damage

b) Permissible radiation exposure

c) Four major hazard classes including three subclasses

d) None of the above

5. The precise targeting of a tissue structure for the purpose of destruction

is called _____________________.

6. Purchase of used laser equipment should include a ________________

________________ report.

7. Classes II -IV must include a warning symbol that states the class and the output power of the product. True or False


Client Medical & Lifestyle History, Consultation,Documentation and Skin Evaluation

I. Client History

A. The skin care professional should take a clienthistory of conditions related to the receiving of laserand light therapy procedures. Relevant topicsinclude but are not limited to, irritant/allergicreactions, Herpes Simplex Virus (cold sore)predisposition, frequency of sun exposure or tanningbed use, topical and/or oral medications(prescription and over-the-counter) all of which mayincrease an individual’s susceptibility to adversereactions. Particular attention should be paid to theuse of topical prescription retinoids and use ofAHAs, BHAs, and other chemical exfoliants(enzymes, proteolytic).

B. An in depth consultation should always beperformed prior to the first laser or light therapytreatment with a review and update of informationprior to each subsequent treatment.

II. Review of Forms

A. Client Consultation FormB. Client Medical and Lifestyle History FormC. Treatment Documentation Form

Specific, detailed documentation of initial and allsubsequent treatments in this form includes:1. Settings2. Number of pulses3. Client response to treatment4. Next return for treatment5. Pre treatment regimen6. Use of ice or gel sheeting7. Use of chiller8. Use of anesthetic cream9. Skin care professional’s name10. Test spot documentation



22. What relevant topicsshould be included ina client history?

23. When should aconsultation beperformed?

24. What scaledetermines UVsensitivity?

25. List 8 precautions totreatment?

26. What are 4indications for a skinrejuvenationtreatment?

27. What pretreatmentrequirements doesthe client need tofollow ?

28. What are 4 posttreatmentrecommendations?

29. What is paramount toperformingt reatments eff e c t i v e l y ?

30. What does a laseroperator need tocomprehend to makeaccurate treatmentchoices?

11. Notation of treatment reaction ifapplicable12. Area treated13. Photographs taken

D. Informed Consent and SignedRelease Form

Written documentation signed bythe client that the skin careprofessional has taken a clienthistory, performed a skin evaluationand discussed the plannedprocedure and post treatment homecare, i.e. avoidance of direct sunexposure, use of sunscreen, etc.

III. Client Expectations

A. Address client questions, concernsand expectations.

B. Set short and long term goals.

IV. Detailed Skin Evaluation

A. Wood’s Lamp/Skin Analysis Device1. Pigmentation evident to the naked

eye but that disappears under aWood’s Lamp/skin analysisdevice is generally seated in theepidermis and will respondfavorably to some laser and lighttherapy treatments.

2. The best results will be achievedwhen used in combination withhome use of tyro s i n a s e-inhibitorsand skin lightening/brighteningproducts.

B . F i t z p a t r i c k ’s Skin Type Classificationp resents a useful scale to determines e n s i t i v i t y levels based onpigmentation and sensitivity to UVradiation exposure.

C . Glogau Classification Chart of PhotoAge Groups is an ideal method for managing client’s expectations whileeducating them as to problems associated with future UV radiation exposure.

Precautions and Contraindicationsto Treatment

I. Precautions to Treatment

A. History of sun exposure and/ortanning bed use.

B. History of irritant/allergicreactions/compromised barrierfunction.

C. Herpes Simplex Virus (cold sore)disposition.

D. Previous chemical and/or mechanicalexfoliation procedures and outcome.

E. History of topical medications, i.e.Tretinoin: Retin-A™, Renova™ (OrthoDermatological), Avita™(Bertek),Altinac™ (Upsher-Smith), Solage™(Galderma).

F. History of oral medications, i.eminocyline, erthromycin, isotretinoin,hormone replacement therapy, birthcontrol methods.

G. History of skin cancer.

H. Previous facial plastic orreconstructive surgery.

I. Current skin care product usage.

J. Client expectations.

K. Clients taking oral anti-coagulants(blood thinners).

L. Tattoos and permanent cosmetics.


M. Avoid raised moles, skin tags, keloidsand scars less than six months old.

N. Vitiligo.

II. Contraindications to Treatment

A.Current isotretinoin users (must be offmedication for at least one year). Isotretinoin: Amnesteem™ (BertekPharmaceuticals), Sotret® (RanbaxyPharmaceuticals, Inc.).

B. History of seizures.

C. Any type of dermatitis includingeczema, psoriasis and seborrhea.

D. Viral lesions including herpes simplexvirus (cold sore), impetigo, warts.

E. Opened or unidentified skin lesions.

F. Sunburn.

G. Clients who are exposed to sunlighton a regular basis, i.e. sunbathe, playsports or work outdoors.

H. Autoimmune diseases (lupus andscleroderma).

I. Bacterial (impetigo, cellulite, boils).

J. Fungal (tinea versicolor).

K. Parasitic (scabies).

L. Cancer/Skin Cancer.

M. Uncontrolled diabetes (poor healingprone to infection).

N. Anyone receiving radiation,chemotherapy for cancer or relatedconditions.

O. Pregnant and or lactating women.

Indications for Treatment

I. Indications for Treatment andMechanisms for Action

A. Hair Removal

1. All areas except eyebrows, molesand suspicious lesions.

2. Light hair colors respond withvariations in outcome.

B. Skin Rejuvenation

1. Hyperpigmentation

2. Telangiectasia

3. Rosacea

4. Fine lines and wrinkles

5. Skin laxity

6. Texture

7. Acne and surgical scar revision

8. Actinic keratosis

9. Seborrhea keratosis

10. Other

C. Vein Treatment

1. Spider veins

2. Vessels 1 - 2 mm

D. Tattoo Removal

E. Acne Prone Skin

F. Psoriasis

G. Body Contouring

H. Other


Pre Treatment Protocol

I. Pre Treatment Preparation of the Skin

A. Stop using three days prior totreatment or as per manufacturer’srecommendation:

1. Alpha and beta hydroxy acids.

2. Benzoyl peroxide.

3. Tretinoin and retinols.

4. Enzymes.

5. Adapalene.

6. Azaleic acid.

7. Other

B. Follow prescribed home care regimenincluding sunscreen.

C. No sunbathing, use of tanning beds ortanning products. No prolongeddirect sun exposure for four weeksprior to treatment.

D. No waxing, electrolysis, or depilatoryuse for four weeks prior to treatment.

E. Remove all products prior totreatment.

F. Shave prior to treatment.

G. Do not exercise for 24 hours after tx.

Laser and Light Therapy TreatmentProtocol

I. Steps in Procedure

A. Complete Client Consultation andObtain Informed Consent and SignedRelease Form.

B. Preparation and Procedure.This time can be used formanufacturer’s demonstrations ofvarious laser and light therapyprocedures.

Post Treatment Protocol

I. Post Treatment

A. Cool compress after treatment. (if applicable)

B Use aloe or soothing products as permanufacturer’s recommendation.

C. Apply and instruct on continuation ofuse of non irritating sunscreen if clientleaves in daylight hours.

D. Provide client with a list of posttreatment product recommendations.

II. Recommendations

A. For 24 hours avoid extreme exercise oranything else that might causeextreme temperature fluctuations.

B. Use tepid water; do not use hot or coldwater, avoid extreme temperatures forinitial 24 hours.

C. No unprotected sun exposure.

D. No exfoliation for five days followingtreatment.


E. No waxing, electrolysis, or depilatoryuse for one week following finaltreatment.

D. Advise client of what to expect andwhat to report to the skin careprofessional.

Recommended Home Care

I. Recommendations for Post TreatmentHome Care

A. Provide client with a list of posttreatment instructions and productrecommendations.

Client Follow-up

I. Frequency of treatments.

II. Side Effect, problems or concerns.

III. Outcomes from the treatment.

Summary

The advancement of lasers and lighttherapy devices continue to flood themarketplace. State regulatory boards thatoversee estheticians using these devicesneed to update scope of practice andcurriculums. While this section may havecovered many of the essentials regardinglaser and light therapy devices, theesthetician must be aware that educationand practice is paramount tounderstanding how to perform treatmentseffectively and safely.

A laser operator needs to comprehendelectricity, physics, safe operation, and thedifferences between each device’sIndication for Use. Obtaining a solidfoundation of theoretical and practicalknowledge will help you to make accuratetreatment choices. These devices canprovide valuable tools for estheticians toobtain remarkable results for theimprovement of numerous skin conditions.



1. A client history should contain:

a) History of allergies

b) Herpes predisposition

c) Medication history

d) All of the above.

2. An informed consent and signed release should be done every treatment.

True or False?

3. List 5 details that should be documented in the treatment notes:

____________________ ____________________ ________________________________________ ____________________

4. Fitzpatrick Skin Type Classification is a useful scale used to determine:

a) Allergic reactivity

b) Aging in relation to UV exposure

c) Sensitivity to UV exposure

d) Tyrosinase-inhibitors

5. Contraindication to treatment means you can do the treatment, just be careful. True or False?

6. A Wood’s Lamp provides evidence of:

a) vascularity

b) location of pigment

c) collagen content

d) dermatitis

7. List four indications for treatment with laser or light therapy:

____________________ ____________________ ____________________ ____________________


laser & light therapy - day spa association

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