a new paradigm for natural skin rejuvenation

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PERFECT SKIN REVEALED

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Illustrated Guide to "needling" - a corrective cosmetic procedure to improve the appearance of fine lines and wrinkles, stretch marks, surgical scars, acne scars, tone and textural imperfections.

TRANSCRIPT

Page 1: A New Paradigm for Natural Skin Rejuvenation

PERFECT SKIN REVEALED

Page 2: A New Paradigm for Natural Skin Rejuvenation
Page 3: A New Paradigm for Natural Skin Rejuvenation

4 INTRODUCTION

5 SKNERGY PEN ADVANTAGES

6-9 ADVANCED TECHNOLOGY

10-14 APPLICATIONS AND EFFECTS

Acne Scars

Fine Lines and Wrinkles

Stretch Marks and Surgical Scars

Skin Rejuvenation

15 IMPORTANT SAFETY INORMATION

16-20 TREATMENT GUIDELINES Pre-treatment Considerations

Instructions for Use

Post-treatment Guidelines

Side Effects

21-26 USER REFERENCE GUIDE Product Overview

Operating the SKNergy Pen

Installing the Needle Cartridge Adjusting the Needle Depth

27 DEPTH BY TREATMENT AREA (ILLUSTRATION)

28 NEEDLE DEPTH AND SPEED CHART

29 TERMS & CONDITIONS

30 PRODUCT SPECIFICATIONS

TABLE OF CONTENTS

Adjusting the Infinite Speed Adapter

Patient’s Post-care Instructions

Instructions for Micro-NeedlingCleaning and Storage of Device

Page 4: A New Paradigm for Natural Skin Rejuvenation

4

INTRODUCTIONSKNERGY PEN - REVOLUTIONARY TECHNOLOGY FOR SKIN REJUVENATION

SKNergy Pen is an FDA-registered Class 1 medical device intended for use by medical professionals in both the aesthetic and clinical settings. SKNergy Pen delivers a minimally invasive procedure, referred to as

healing process using Collagen Induction Therapy (CIT) to encourage the production of collagen and elastin. Indicated for a variety of skin types, results are typically immediate and direct with noticeableimprovement of skin’s overall tone and texture, fine lines and wrinkles, acne scars, stretch marks and hyperpigmentation.

BARRIER NEEDLE CARTRIDGEUtilizes twelve 32-gauge needles

developed from the highest quality surgical

grade stainless steel. The silicone barrier

sheath design prevents both fluid leakage

and cross contamination. The SAFETY CATCH is a uniquesecurity feature that ensures needlecartridges are locked into place forsafe and effective treatments

PROTECTIONThe SKNergy Collagen StimulationSystem delivers consistent micro-injuriesacross the entire treatment area whileleaving the epidermis intact.

PRECISIONThe Precision Dial allows for an adjustableneedle depth range of 0.25mm to 2.5mm,enabling customizable treatments for eachpatient's individual skincare needs.

POWERA Robust High Torque German Motor ensuresgreater consistency, delivering precise micro-injuries at up to 14000rpm across the entiretreatment area - significantly faster and muchmore predictable than other collagen stimulationtechnologies.

DESIGN

VERSATILITY

The sophisticated, sleek design isergonomic and lightweight, resulting ineffortless gliding across the skin thereby reducing motion fatigue.

One device with multiple treatmentapplications, designed to deliverresults for a variety of skin types.

INDICATED FOR ALL SKIN TYPES TO TARGET

• Fine Lines and Wrinkles

• Skin Rejuvenation

• Stretch Marks (Striae)

• Atrophic Acne Scars

• Non-Keloidal Hypertrophic

Scars

• Skin Laxity

• Skin Texture

SKNergy's Infinite Speed Adapter offers 5variable speeds with an output up to 14,000rpm, ideal for achieving a deep dermal repair effecton scars and stretch marks

Cordless Lithium Battery operates up to6 hrs at an output of 10000rpm -superior for facial rejuvenation

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micro-needling, designed to stimulate the body’s natural wound

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SKNERGY PEN ADVANTAGES The SKNergy Pen procedure utilizes tiny microneedles to deliver a non-invasive and unique collagen stimulation treatment alternative to ablative laser resurfacing, microdermabrasion, chemical peels and other aesthetic procedures, effectively promoting deep dermal repair while allowing the epidermis to remain intact.

Many therapies that offer improvement in facial scars, such as CO2 laserresurfacing and dermabrasion, are invariably associated with considerable morbidity and downtime, thereby interfering with the daily activities of patients in the post-treatment period. However, treatments utilizing micro-needling or non-ablative laser resurfacing are associated with minimal or no downtime. Additionally, micro-needling does not damage the skin or remove the epidermal layer, making it the gold standard for a variety of skin types and needs.

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ADVANCED TECHNOLOGY1995 - Orentreich and Orentreich described subcision or dermal needling for scars.

1997 - Camirand and Doucet described needle dermabrasion using a tattoo

1997 - Micro-needling introduced as a new treatment modality utilizing adevice called a dermaroller, indicated for use in targeting improvement of

2006 - Fernandes developed Collagen Induction Therapy (CIT) using a dermaroller, initiating the natural post traumatic inflammatory cascade byrolling needles vertically, horizontally and diagonally - with pressure - over the treated area.

Clinical BenefitsSafe For All Skin TypesHigh Dermal RepairMinimal Epidermal EffectLow Consumables

Patient BenefitsMinimal or No DowntimeNon-InvasiveImmediate ResultsCost Effective

SKNergy Barrier Needle Cartridge

pistol to administer the treatment.

the appearance of scars.

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ADVANCED TECHNOLOGYMicro-needling is a non-ablative procedure that utilizes sterile, surgical grade stainless steel needles to create thousands of precise micro-wounds in the dermis, while leaving the epidermis intact and without causing anydamage to the stratum corneum or basal membrane.These superficial micro-wounds trigger the wound healing inflammatorycascade, which is the skin’s natural response to repair itself.

The natural stimulation process is almost immediate, promoting collagen and elastin formation in the extracellular skin matrix. Micro-needling is used in Collagen Induction Therapy (CIT) to initiate the three-phase processof the wound healing inflammatory cascade.

Phases of the Wound Healing Inflammatory Cascade

5

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ADVANCED TECHNOLOGY

PHASE 1: INFLAMMATION

The first phase of CIT therapy is initiated by the delivery of micro-needles into the epidermis and dermis, causing a micro-injury and inflammation at the epidermis-dermis junction. This micro-injury subsequently triggers a release of growth factors and the cascade of new epidermal growth, fibroblast, chemotaxis, fibroblast proliferation and matrix production.

PHASE 2: PROLIFERATION

The second phase involves a wound healing process occurring in various mechanisms such as epithelialization, angiogenesis, and collagenesis. This proliferation phase continues to release platelet derived growth factors, fibroblast growth factors, and transforming growth factors α and β. Growth factors from fibroblasts, keratinocytes and monocytes culminate in this second phase of (CIT) mechanics where collagen III, IV and I, elastin, proteoglycans, GAG’s (glycosamaminoglycans) and angiogenesis occur.

PHASE 3: REMODELING

The third phase of the CIT process involves a continual healing and remodeling process which typically extends over a period of one year or longer. In this third and final phase, collagen III is converted to collagen I in the upper dermis of the skin.

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ADVANCED TECHNOLOGY

The skin consists of the epidermis and the dermis, the thickness of which varies depending on the area of the body and the individual. The epider-mis is approximately 0.1 to 0.2mm thick. The dermis is approximately 1 to 2mm thick. The SKNergy Pen typically produces the best results with a 1.0mm to 1.5mm needle depth, focusing on repairing the epidermal-dermaljunction.

IMPORTANT – Needle depth recommendations are to be used only as a general guideline, as individual skin thickness and conditions will vary results. Before beginning any treatment it is recommended that a test patch is initially undertaken to observe any noticeable signs of delayed wound healing, excessive erythema or TEWL (trans-epidermal water loss).

SKNergy Pen treatments are to be used only with the surgical grade SKNergy Barrier Needles.

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APPLICATIONS AND EFFECT

Procedure Targets:

SKNergy Pen collagen stimulation treatments are for all skin types, improving skin’s overall tone and texture by brightening and tightening with virtually no risk or downtime for the patient.

• Fine Lines and Wrinkles

• Skin Rejuvenation

• Stretch Marks (Striae)

• Atrophic Acne Scars

• Non-Keloidal Hypertrophic Scars

• Skin Laxity

• Skin Tone & Texture

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Rebuild collagen for

vertical frown lines

Brightens skin tone from sun damage

& hyperpigmentation

CHEEK

CHEEKBONEStrengthens and firms thinning skin

Plumps nasolabial and marionette lines

Rebuilds rolling, raised,

deep and discolored

scars including stretch

marks

Stimulates collagen minimizing horizontal

forehead lines

Refines crow’s feet lines

Smooths uneven skin textures from acne

scars and enlarged pores

Resurfaces aged, lax skin on

the neck and chest

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ACNE SCARS

To effectively keep acne under control and diminish post-acne pigmenta-tion and reduce or prevent infections from reoccurring, use caution when treating scars formed by infections. Start and proceed slowly and be sure to test a small area first. When treating acne scars the needle depth and speed will depend on the thickness of the individual’s skin. Best results are typically seen after 6 treatments, scheduled 4 to 8 weeks apart.

• Rolling Scars – suggested use is a 1.0 mm needle depth on medium to high speed.• Post-Acne Pigmentation – suggested use is a 0.5 mm or a 1.0 mm needle depth on low to medium speed.

Note – For acne scars on the cheek and cheekbone the skin needle depth can be adjusted from 0.5 mm to 1.5 mm and, depending on the patient’s individual skin type, the speed can be adjusted and increased from low to medium speed for thin skin, and adjusted from medium to high speed for thicker skin. Never use aggressive needling.

BEFORE AFTER

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SKIN FIRMING & TIGHTENING

SKNergy Pen treatments can improve skin elasticity, trigger collagen production and improve overall tightening of the skin. The recommended needle depth for skin rejuvenation and diminishing wrinkles on the face will vary depending on the density of the patient’s skin folds, depth/severityof wrinkles and area of the face. • Vertical lines (wrinkles between the eyebrows) and horizontal lines (wrinkles on forehead) - start needle depth at 0.25 mm, increasing depth up to 1.0 mm, on low to medium speed.

• Crow’s feet (wrinkles around the eyes) - adjust needle depth from 0.25 mm to 0.5 mm on low speed. Do not micro-needle under the eyelid.

• Nasolabial fold (deepening skin folds on the cheeks) - adjust needle depth from 1.0 mm to 1.5 mm on medium to high speed.

• Perioral (wrinkles around the lips) - adjust needle depth from 0.25 mm to 0.5 mm on low speed.

BEFORE AFTER

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SCARS AND STRETCH MARKS

SKNergy Pen’s new and exclusive “Infinite Speed Adapter” powerfully penetrates the deep skin matrix for scar revisions, and provides the capability of operating at speeds from 10,000rpm up to 14,000rpm. This high-speed adapter offers a more effective option for softening deep scars and triggering production of new collagen and elastin. Additionally, when using a micro-needling device with a higher RPM, the clinician will usually experience less pulling and the patient will typically experience less discomfort.

SKNergy Pen’s Infinite Speed Adapter is designed to soften and plump up scars on the face, abdomen, back, arms, hands and buttocks. Scar revisions include stretch marks and both long and short surgical scars.

• When treating stretch marks and for deep dermal revisions, best results are seen using the Infinite Speed Adapter on a medium to high speed (level 3 - level 5). • Optimum results are typically seen with 6 to 8 treatments scheduled every 6 weeks.

BEFORE AFTER

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SKNergy treatments promote the turnover of new skin, improving the appearance of sun/age spots, melasma and brownish pigmentation resulting from increased melanin production. Melanin production istriggered by exposure to the sun, as well as reactions to skin injuriesor prolonged inflammation. SKNergy treatments are effective in greatly improving pigmented skin when proper sun protection is used, followed by the proper skin care regimen. Sun exposure should be avoided completely for at least 48 hours in order to obtain optimum results.

• Needle depth and speed level will be determined by the area and condition being treated.

BEFORE AFTER

SKIN REJUVENATION

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INTENDED USESKNergy Pen is intended to reduce and improve the appearance of skin imperfections such as fine lines and wrinkles, acne scars, stretch marks and hyperpigmentation in areas such as the face, chest, hands and abdomen.

CONTRAINDICATIONSThe use of the SKNergy Pen is contraindicated for patients with the following pathological conditions:• Active skin cancer;• Warts and actinic keratosis;• Patients suffering from psoriasis, collagen vascular disease, chronic dermatitis

and chronic eczema;• Skin burns that are less than 6 months old;• Active acne vulgaris or rosacea;• Open wounds or sores;• Active herpes labialis infections;• Skin bacterial, viral or fungal skin infections;• Patients who are on anticoagulant therapy, such as Warfarin or Heparin• Patients suffering from any blood clotting disorder;• Patients allergic to any general, local or topical anesthetic;• Patients receiving chemotherapy or radiation therapy;• Patients receiving corticosteroid therapy;• Patients suffering from diabetes or mellitus• Patients with a history of lupus.

PRECAUTIONS AND WARNINGSSKNergy Pen treatments have not been evaluated in the following populations, and as such, precautions should be taken when determining whether to treat the following:• Patients with scars and stretch marks less than one year old;• Women who are pregnant and/or nursing;• Patients who have had Botox and/or filler injections within 48 hours or less;• Patients taking vitamin E and/or omega-3 should be advised to discontinue use 7 days prior to micro-needling treatments, as it may increase the risk of bruising. Caution should be exercised with immunocompromised patients, as micro- needling can cause secondary infections.• Isotretinoin therapy should be stopped at least 6 months prior to micro- needling, as this may result in delayed wound healing. Avoid the use of retinoids, alpha-hydroxy acids and hydroquinone 3 days prior to treatment.

IMPORTANT SAFETY INFORMATION

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• The patient should avoid any significant sun exposure at least 48 hours prior to any micro-needling procedure.• The patient should discontinue use of retinoids, alpha-hydroxy acids, topical acne medications and hydroquinone at least three days prior to treatment.• Avoid micro-needling treatments on patients with active acne, inflam- matory papules, pustules, active dermatitis, cystic nodules, active herpes labialis infection, impetigo, psoriasis, vitiligo or any other active inflammatory or infectious diseases due to bacteria or virus.• Pre-treat with anti-viral medications if the patient has a history of herpes labialis.• Wait at least six months to perform any micro-needling treatment following isotretinoin use.• Fitzpatrick Skin Types IV-VI should be cautioned that post-inflammatory hyperpigmentation may occur. This is a temporary discoloration of the skin that will lighten with time. A test spot may be indicated and suggested for these patients.• Explain the micro-needling procedure to the patient, and be sure to have a comprehensive discussion of the risks and benefits of this treatment. Common risks may include erythema, pinpoint bleeding, bruising, swelling, pain and infection.• Ensure that the patient has not taken any photosensitizing medications, and has avoided topical medications or skin care creams previously referenced in the Pre-Treatment Precautions section. If necessary, further ensure that the patient has been pre-treated with an anti-viral medication if needed. The patient should also be given a treatment consent form to execute at this time, and be given post-op instructions as well.• It is recommended that the practitioner take “before” and “after” pictures of the patient from each angle – i.e., right, left and front photo of the treatment areas at each appointment.

PRE-TREATMENT CONSIDERATIONS

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PART ONE

• Prep the skin by cleansing the patient’s face with a gentle cleanser to remove any dirt, make-up or other debris. Wipe the skin down with rubbing alcohol to prepare the skin for micro-needling. Caution: Using acetone on the face is not recommended. • Apply a topical anesthetic cream to the treatment area and leave on for 45 minutes, or the recommended timeframe based on product instructions.• Remove the topical anesthetic cream and cleanse the face again with alcohol.• Load the sterile SKNergy Barrier Needle Cartridge into the head of SKNergy Pen. (See User Reference Guide for Operating Device) Note: Inspect the micro-needle cartridge for any damage before starting the treatment.

PART TWO

• Prep treatment area by applying a thin layer of SKNergy Ultrapure Hyaluronic Acid Treatment Gel to aid in gliding the SKNergy Pen. This will also decrease the risk of scratching the area being treated. Do not apply a thick layer of gel, as this may clog the needle cartridge.• Start the procedure with a depth setting of 0.5 mm. If an even erythema is not initially observed, gradually increase the needle depth by adjusting the Precision Dial setting to achieve an even distribution of erythema.

NOTE: Settings may vary depending on skin type, sensitivity of patient’s skin, thickness of patient’s skin and area being treated. Start at a lower setting of 0.25 mm when performing micro-needling to the forehead or periorbital area.

INSTRUCTIONS FOR USE

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PART THREE

• Perform the treatment/procedure in four (4) sections, starting with the right cheek, then left cheek before finishing with the left and right forehead. It is best to begin the treatment on the cheek, as the forehead is more sensitive. • Hold the skin taut while moving across the right medial cheek, moving outward toward the jawline in one direction. Then, change directions in a cross-hatching pattern. Lastly, move in a circular motion. Repeat this pattern until even erythema has been achieved. Repeat this procedure on the left cheek.• Move to the nose, chin and upper lip. These areas may be more sensitive, requiring less needle depth and less fewer passes. Move upward, across and in a circular pattern on the chin. Move upward and across on the upper lip. For ease, have the patient place their tongue over their upper teeth (placing the tongue inside the cheek under the nasolabial folds and other soft areas as well as provides counter pressure for adequate needle tension).• Treat the forehead in an upward and across motion, ending with a circular motion. Lastly, treat the periorbital area gently on the lowest setting of 0.25 mm. Be sure to watch for petechiae (small subcutaneous hemorrhages), bruising and/or scratching. Discontinue further treatments or passes of these areas immediately if any of these signs occur.• Two passes are typically sufficient for most patients; however, some patients may require more passes in certain areas. The underlying objective is to closely observe for diffuse erythema to the treated area. After two passes, wait a couple of minutes to ensure the patient is achieving diffuse erythema. Some patients may have a delayed erythematous response, so it is important to closely monitor and observe the patient’s progress and appearance during the procedure. Treat only those areas that have not achieved erythema with a third pass.

INSTRUCTIONS FOR USE

• Wipe off any blood that surfaces during treatment with sterile saline water.A dabbing action with a sterilized cotton swab is preferred over wiping, asit is typically less irritating to the patient.

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• Gently dab any bleeding skin using sterile saline water and sterile cotton swabs.

• Reapply a thin layer of hyaluronic acid gel. This will provide a cooling action, as a result of the gel’s evaporation from the skin.Caution: It is recommended to apply only a hyaluronic acid gel after treatment. The patient should not apply sunscreen, moisturizers or any makeup until at least the following morning.

• NSAIDs can be prescribed to decrease any discomfort and/or inflammation.

• The patient should be advised to avoid sun exposure for the remainder of the day, and until any erythema has fully resolved.

Side effects observed are generally mild and typically begin to diminish within 24 hours. After 3 days the skin should generally appear healed. The most common side effects after the procedure are summarized below:

• Irritation, mild bruising and swelling; mild – moderate erythema;• Acne breakouts (white heads) may occur, especially on the chin;• Minor and brief bleeding;• Milia;• Herpes simplex breakouts (rare): pre-treat the areas where the lesions

are known to occur or avoid completely;• Hematomas; superficial granulomas have been reported in some cases

POST TREATMENT GUIDELINES

SIDE EFFECTS

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DAYS 1 AND 2:

• The patient can start or resume his/her normal skin care regimen after any erythema has disappeared, or the patient is otherwise feeling comfortable.• It is recommended to only use SKNergy Hydra-Pure Daily Recovery Serum Gel for the first 24 hours post-procedure, and avoid using sunscreen or any makeup until at least 12 hours after treatment. • The patient should apply a linoleic/linolenic acid-based moisturizer to combat dryness of the skin for approximately 1 to 3 days post treatment. • The patient should limit his/her exposure to the sun, and can begin to wear sunscreen 12 hours post treatment.• Patients should also avoid exercise and any excessive perspiration during this time (perhaps longer if the patient is still erythematous).

DAY 3 AND BEYOND:

• The patient is usually able to resume their normal skin care routine by Day 3, if the erythema has subsided.• It is suggested that the patient consider using a Vitamin A and/or Vitamin C-based cream(s) for at least six (6) months after any micro- needling procedure, as Vitamin A and Vitamin C creams are generally considered to help promote collagen formation.• The next session of micro-needling should usually be performed within 4-6 weeks after the first session. Collagen formation can start within 6 weeks and continue for up to 12 months or long er. Patients may require three to six treatments depending on the condition being treated (or more, especially if treating acne scarring, moderate to severe rhytids and textural changes).

PATIENT’S POST-CARE REGIMEN

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ONE DEVICE, MULTIPLE TREATMENT APPLICATIONS

PRODUCT OVERVIEW

The SKNergy Pen has a speed output range of 10,000rpm - 14,000rpm. The 5 variable speeds can be modulated using the Infinite Speed Adapter.The depth and speed of the micro-needle can be adjusted depending uponthe area of the skin and the condition(s) being treated. SKNergy Penachieves gold standard results utilizing a single-use, sterile, surgical grade12-needle cartridge.

USER REFERENCE GUIDE

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Infinite Speed Adapter SKNergy Pen Barrier Needle Cartridge

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OPERATING THE SKNERGY PEN

SKNergy Pen’s unrivaled technology utilizes SKNergy Barrier Needles, designed with the patient’s safety and protection as the number one priority. The 12 surgical grade 32-gauge needles in each cartridge optimize patient safety and results, delivering precise micro-injuries at up to 14,000rpm. The needle depth can be adjusted from .25mm to 2.5mm, allowing controlled induction into the deep dermis to stimulate the production of new collagen and elastin without any disruption to the epidermis.

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PERFORMANCE -The 12 surgical grade 32-gauge SKNergy Barrier needles deliver over 2800 micro-injuries per second - the highest performing micro-needle cartridge on the market - while minimizing epidermal disruption.

PROTECTION - The extra thick 2mm Silicone Sheath helpsensure patient safety by preventing cross contaminationand fluid leakage or damage to theSKNergy Pen

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INSTALLING THE MICRO-NEEDLECARTRIDGE

Remove the disposable micro-needle cartridge from the sterile packaging.Load the SKNergy Barrier Needle Cartridge into the head of SKNergy Penby rotating it in a clockwise direction until it catches on the Safety Catch,which will lock the needle cartridge in place.

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The Safety Catch is a unique design featurethat locks and securesthe needle cartridge into the pen for safe andeffective treatments.

IMPORTANT: Always ensure that the Precision Dial that controls the depth of the needles is set to its lowest value, “0”, before installing a micro-needle cartridge. (See Adjusting the Needle Depth, pg. 24) After the treatment, remove the micro-needle cartridge by rotating it in acounterclockwise direction. The sterile micro-needle cartridge is for onetime use only and should be disposed of in a biohazard Sharps container

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after use.

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ADJUSTING THE NEEDLE DEPTH

The Precision Dial adjusts the needle depth from 0mm to 2.5mm, allowing controlled induction into the deep dermis to stimulate the production of new collagen and elastin.

The micro-needle depth can be adjusted from 0 mm (minimum depth setting) to 2.5 mm (maximum depth setting) by turning the Precision Dial in a clockwise or counterclockwise direction. The sensitive parts of the face, such as lips and forehead, require a lower needle depth while less sensitive parts of the skin require a higher needle depth.

Step 1: Always make sure the Precision Dial is set to “0” before installingmicro-needle cartridge.Step 2: Set the Precision Dial to the appropriate depth after installing the cartridge. A depth of 0.5mm to 2.5mm is termed ‘medical needling’ on theSKNergy Pen. See the Needle Depth and Speed Chart, pg. 28, for

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The Precision Dial adjusts the needle depth from0mm to 2.5mm, allowing controlled induction into the deep dermis to stimulate the production of newcollagen and elastin

recommended needle depth settings.

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ADJUSTING SPEED LEVELS USING THE INFINITE SPEED ADAPTER

The 5 variable speeds, ranging from 10,000rpm - 14,000 rpm, of the SKNergy Pen can easily be adjusted using the Infinite Speed Adapter by turning theSpeed Dial clockwise for faster output and counterclockwise for slower output. The customizable needle depths and elective speed controller ensuremaximum results for deep dermal repair.

Step 1: Install a new, unused SKNergy Barrier Needle Cartridge ontothe SKNergy Pen before initiating a new treatment. Load the cartridgeonto the SKNergy Pen by rotating it gently in a clockwise direction until it locks into the Safety Catch.

Step 2: Choose the desired treatment speed on the Infinite Speed Adapter, and set the micro-needle depth using the Precision Dial. (Refer to the Needle Depth and Speed Chart, pg. 28)

Before beginning a SKNergy Pen treatment, it is recommended to use a topical anesthetic. Detailed instructions for micro-needling are provided in the next section, and see Treatment Guidelines section, pages 16-18, forfull usage instructions.

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........ ......................... .......... ............ ..... .............SPEED ADAPTER ON/OFF BUTTON

5 SPEED DISPLAY1-2 LOW 10,000rpm – 11,000rpm3 MEDIUM 12,000rpm4-5 HIGH 13,000rpm – 14,000rpm

POWER CORD.......................

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INSTRUCTIONS FOR MICRO-NEEDLING

Step 1: Apply a thin layer of SKNergy Ultrapure Hyaluronic Acid Micro-Needling Treatment Gel onto the skin.

Step 2: Start the treatment with SKNergy Pen by gently gliding the pen perpendicular to the skin’s surface, without pressing into the skin. To complete the treatment, adjust the SKNergy Pen to the appropriate depth and speed as indicated. Move the pen using a gentle circular rolling method over the entire face for the final pass.

Step 3: After the treatment, remove the micro-needle cartridge by rotating it in a counterclockwise direction to unlock it from the Safety Catch. Properly dispose of the used cartridge in a Sharps container. The sterilemicro-needle cartridge is to be used only once.

CLEANING AND STORAGE OF DEVICE

Clean and disinfect the SKNergy Pen using medical sanitizer or alcohol with a gauze pad and cotton swab after every treatment.Place the SKNergy Pen in its protective storage case and charge it before/after each use.

Device should always be stored at room temperature. Never leave devicein high temperatures, as excessive heat will rapidly diminish battery life.

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0.25 - 1.5 MM

0.25 - 1.5 MM

0.25 - 0.5 MM0.25 MM

0.5 - 1.5 MM

0.5 - 2.5 MM

0.25 MM

0.5 - 1.0 MM

0.25 - 2.0 MM

ILLUSTRATION OF DEPTHS BYTREATMENT AREA

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NEEDLE DEPTH AND SPEED REFERENCE CHART

REGION NEEDLE DEPTH (mm) THIN SKIN THICK SKIN

FOREHEAD

BETWEENEYEBROWS

NOSE

EYE AREA

CHEEKBONE

CHEEK

LIPS

ABDOMEN

HANDS

0.25 - 1.5 MM

0.25 - 1.5 MM

0.25 - 0.5 MM

0.25 MM

0.5 MM

1.0 - 1.5 MM

0.25 MM

1.0 - 2.5 MM

0.25 - 1.0 MM

LOW

LOW

LOW

LOW

LOW

LOW

LOW

MEDIUM

LOW

LOW OR MEDIUM

LOW OR MEDIUM

LOW OR MEDIUM

LOW

LOW OR MEDIUM

MEDIUM OR HIGH

LOW

HIGH

MEDIUM

CHIN 0.25 - 2.0 MM LOW LOW OR MEDIUM

CHEST 0.5 - 1.0 MM LOW LOW OR MEDIUM

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SKNergy Aesthetics guarantees and warrants the SKNergy device to be free from defects for one (1) year from the date of purchase. If the aforementioned product is found to be defective within the warranty period, the original purchaser should contact Customer Service for reimbursement or replacement.

THIS EXPRESS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES, WHETHER EXPRESSED, IMPLIED OR STATUTORY, INCLUDINGIMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULARPURPOSE.

Use of the products referenced herein represents an express acknowledgementby the user that such use is being undertaken at the user’s own risk; and, in doingso, the user further agrees that SKNergy Aesthetics’ liability regarding any of theproducts referenced herein shall be limited to an amount not to exceed the pricepaid for the products(s). The foregoing shall constitute the exclusive remedy forthe original purchaser and/or user.

SKNERGY AESTHETICS’ MAXIMUM LIABILITY, IF ANY, FOR ALL DAMAGES, INCLUDING WITHOUT LIMITATION, CONTRACT DAMAGES AND DAMAGESFOR INJURIES TO PERSONS OR PROPERTY, WHETHER ARISING FROM ANYBREACH OF THE AFOREMENTIONED WARRANTY, AND/OR ITS ALLEGED NEGLIGENCE, STRICT LIABILITY OR ANY OTHER TORT OR CAUSE OF ACTIONIS LIMITED TO AN AMOUNT NOT TO EXCEED THE PRICE OF THE PRODUCT(S)PURCHASED.

In no event shall SKNergy Aesthetics have any liability whatsoever for any direct,indirect, punitive, incidental, special or consequential damages, to property orlife, arising out of or connected with the use or misuse of its products, regardlessof whether it is claimed that SKNergy Aesthetics knew or should have known ofthe likelihood of any loss or damages.

All orders and disputes between the parties shall be construed, interpreted and the rights of the parties determined in accordance with the laws of the State ofFlorida without giving effect to conflict of law principles. Any controversy or dispute arising out of or in any way relating to these terms and conditions, or theproducts sold by SKNergy Aesthetics, shall be resolved by a court of competentjurisdiction situated in Orange County, Florida, and the purchaser and/or userof the products sold by SKNergy Aesthetics irrevocably consents and submits tothe exclusive jurisdiction of such court for the resolution of any such dispute.SKNergy Aesthetics shall be entitled to recover its costs and reasonable attorneys’ fees incurred in the enforcement or defense of any of its rights set forth herein.

TERMS AND CONDITIONS

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PRODUCT SPECIFICATIONS

MATERIAL

BATTERY CAPACITY

BATTERY DURATION

POWER SUPPLY

POWER SUPPLY OUTPUT

ROTATION SPEED RANGE

ADJUSTABLE NEEDLE DEPTH

MOTOR

DIMENSION PEN/UNIT

PRODUCT WEIGHT

WARRANTY

HIGH QUALITY ALLOY, ABS

LITHIUM POLYMER, 4.2V/650MAH

UP TO 6 HOURS

INPUT AC100-240V, 50/60HZ

DC5V 1A

10,000-14,000 RPM (LOW 1-2; MEDIUM 3; HIGH 4-5 )

0 - 2.5 MM

1 YEAR

GERMAN MOTOR

SKNERGY PEN: 70G /BATTERY: 20GRECHARGE STANDS: 10GADJUSTABLE SPEED ADAPTER HEAD: 20G/ADAPTER: 85G

L1 40MM X 20MM (WITH BATTERY) / 29 X 24 X 6.5CMALLOY CASE

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