SkinPen® Precision Microneedling. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017. More (210) 947-2640. SkinPen™ Microneedling Treatment. The SkinPen® Precision system is a microneedling device and accessories intended to. Natural Recovery: SkinPen’s mechanical process is versatile and usable year-round. Power on by pressing and holding the on/off button on the front of SkinPen® Precision for one second. SkinPen Precision is the most trusted microneedling technology on the market and has truly revolutionized skin remodeling treatments for all. Welcome to Bare Skin Clinic, where advanced skincare meets inclusivity. SkinPen™ is the first FDA approved microneedling device and has been proven to produce results that. i poparte ponad 90 badaniami walidacyjnymi*, to najwyższej klasy produkt do remodelowania skóry zaprojektowany i wyprodukowany w. "Great service all around. It is intended to be used as a treatment to improve the appearance. Available only through skin care professionals, SkinPen is a medical-grade, state-of-the-art precision tool. Quiet operation (does not exceed 70 decibels at a 3-foot distance) More than 2000 hours of use in the life of the pen (approximately 4000 treatments) Become a SkinPen pro. $ 3,900 $ 3,650. The SkinPen® Precision system is a microneedling device and accessories intended to. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. SkinPen Precision is also the only microneedling device with software validation to guarantee performance of its smart technology. Food and Drug Administration, clinically proven to treat facial acne scars safely and effectively for ages 22 and up. 4430 Same . Kim Weeks, R. MicroPen EVO™ SkinPen® Precision System NA . Ho. outer diameter of 34mm Electrical Requirements Input voltage: 4. Best of all, SkinPen doesn’t rely on heat or chemicals, so the results. Saturday 10. “Radiofrequency treatments can tighten the tissues just underneath the skin surface and contour the face, creating firm, toned, youthful-looking. Microneedling aktiviert die natürliche Heilkraft Ihres Körpers für die Haut, um den Kollagen- und Elastingehalt zu erhöhen, damit Ihre Haut wieder gesünder und jünger. Ensure the needle is set to “0” before starting a new procedure. Παραμείνετε λαμπερή με φυσικό τρόπο. Have your SkinPen procedure performed at Singing River CosMedics by an official SkinPen Provider and experienced Certified Nurse Practitioner. DALLAS, Oct. Downtime following the procedure is minimal, redness persists for 24-48 hours following the procedure. Bellus Medical SkinPen Precision in good operating condition and ready for use. com. Monroe St. Not Just Faces, Medical Aesthetics can provide additional information regarding Skinpen Precision System preparation and post-treatment practices. 00 - Offered by Hannah James and Megan Vernelli, RPNSkinPen Precision is the first FDA-cleared and Health Canada approved Micro-needling Device. A SkinPen javallott továbbáSkinPen, the first-ever FDA-approved microneedling device, is a minimally invasive tool that uses sterile needles to create tiny holes in your skin. . Biocellulose. 2. With a roller the needles penetrate the skin at an angle causing more chance of tears through the. The SkinPen® Precision System is a microneedle anti-wrinkle device for all skin types. TikTok video from CS Medical Aesthetics (@csmedicalaesthetics): "No better way to have self care than with @SkinPen® Precision #microneedling #skinpenmicroneedling #skinpen #skintok #skintreatment #selfcaretiktok #selfcare #aestheticsnurse #face #CapCut". 9) Minimum, Median, Maximum 23, 48, 60 21, 46, 60 N (%) N (%) Sex Male 7 35 13 31. Aesthetic Purposes: SkinPen® Precision Microneedling System is also intended to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical. It will improve acne scars, wrinkles, fine lines, lax skin, along with remodelling collagen within the dermis for up to year from 1st treatment. With as few as three non-invasive and affordable treatments spaced 30 days apart, you can improve your appearance for six months after. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. . outer diameter of 34mm Electrical Requirements Input voltage: 4. MicroPen EVO is FDA-cleared to improve the appearance of wrinkles of the neck and facial acne scars for people aged 22 and above. 4430 Regulation Name: Microneedling Device for Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: February 18, 2022 Received: February 22, 2022 Dear Marie Fogartie: We have reviewed your Section 510(k) premarket notification of intent to market. SkinPen Precision System Comparison . SkinPen is a minimally invasive, in-office, skin rejuvenation procedure that improves fine lines, wrinkles, acne scars, hyperpigmentation, stretch marks and other conditions by stimulating your skin’s natural ability to repair itself. 13, 2022 /PRNewswire/ -- Crown Aesthetics, a division of Crown Laboratories and the global leader in microneedling technology, is proud to share that SkinPen. Duration of new, bright and healthy skin depends on your skin type and lifestyle. New other (see details) $109. Founder Hannah established Ink & Glow in 2018, leaving behind a successful career in buying. 12. Procedures take about 30 minutes depending on the area treated and the desired results. , is happy to announce that SkinPen Precision (“SkinPen”), the first microneedling device cleared by the FDA and the global leader in skin remodelling, now has a direct presence in Germany, the largest aesthetic market in Europe. 13 Oct, 2022, 08:22 ET. $ 65 – $ 600. Crown Aesthetics (“Crown”), a division of. A. 95Standard Shipping | See details. Monday 9. The result is more youthful and tighter looking skin. 30 – 6. Aesthetics, Crown Aesthetics ,. The variable depth. SkinPen™ is the first FDA approved microneedling device and has been proven to produce results that last up to six months. SkinPen® Precision, by Crown Aesthetics, is the first microneedling device cleared by the U. Friday 9. It is the only FDA-approved microneedling device on the market. Dear Patients. $325 and up SkinPen Precision FACE+NECK. SkinPen Precision System All Subjects N 20 41 Age (years) Mean (standard deviation) 43. Find a Location. SkinPen. “SkinPen was the first induction therapy with needling to obtain an FDA clearance. Crown Aesthetics is a division of Crown Laboratories, Inc. This revolutionary microneedling device is licensed by Health Canada and is the only one approved by all three other key regulatory bodies in the world: the US FDA, EU. 11. SkinPen® Precision is a microneedling device that utilizes Collagen Induction Therapy to treat acne scars, surgical scars, and fine lines & wrinkles by creating temporary small microscopic channels in your skin. Maryland Metro; Minnesota. 1. SkinPen has passed more than 90 validated tests to set the standard in microneedling. Golden Year - Official Sound Studio. 25 mm: N/A: Most people, particularly those new to microneedling or those on a budget: Dr. The disposable cartridge and adjustable needle depth in SkinPen micro needling are the two main features that help practitioners work with utmost precision. Not all treatments available / External practitioners only / fully manned reception for all booking enquires. [2] ProGen™ intended use: The ProGen PC Kit is indicated for the rapid. 1920 Stanley Gault Parkway, Ste. DermaSculpt is a blunt, flexible microcannula for atraumatic filler injections. $ 470. The SkinPen® and needle cartridge slip into a single-use nonsterile and disposable BioSheath to prevent cross-contamination. 00. It also has the added benefit of correcting harsher pigment issues and discolorations than the SkinPen. SkinPen Precision is suitable for all skin tones and types (Fitzpatrick I-VI) Offering a. 00. Marketing Manager. SkinPen's handpiece is ergonomically designed. • SkinPen ® Precision System (DEN160029) manufactured by Bellus Medical, LLC. SkinPen Precision es un dispositivo de microagujas que activa el proceso natural de cicatrización de heridas de la piel para tratar cicatrices de acné y ayuda a mejorar la apariencia de líneas de expresión y arrugas, cicatrices quirúrgicas, estrías y agrandamiento de poros. 97:SkinPen Precision is a class IIa medical device included on the ARTG indicated to treat acne scarring, surgical scars and fine lines and wrinkles . Radiofrequency treatments are among some of the most popular non-invasive face ‘lifting’ tweakments, and best known for their firming powers. Melissa is certified in Dermal fillers, Advanced injectables, Neuromodulators (Botox®, Xeomin and Dysport®), Kybella, SkinPen Microneedling with PRP, PRP or PRIMAzome injections and various Lasers. A beavatkozást követő első és hatodik hónapban résztvevők 85%-a volt elégedett és 90%-a ajánlotta volna a SkinPen Precision kezelést barátainak, családtagjainak. Contact Data CONTACT: ResearchAndMarkets. U. S. The SkinPen Precision Global London Symposium will be taking place on October 1 at 9am-5:30pm GMT at the Cavendish Conference Centre, London. 18 Nov, 2020, 05:03 ET. 07 Mar, 2023, 08:26 ET. Zu den. Beauty & Lash ArtistryWe would like to show you a description here but the site won’t allow us. CALL NOW (949) 489-1858 LEARN MORE. Regulation # 21 CFR Part 878. 30 Mar 2022. SKINPEN® PRECISION IST FÜR SIE IN DEUTSCHLAND DA: Öffnungszeiten: Montag - Freitag 9:00 - 17:00 Uhr. The best for professional use: SkinPen® Precision ($$$$) Microneedling Comparison Chart. QAI QAI Same . intended use: The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II – IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years. You can also complete the online contact form on our website to schedule a consultation today. SkinPen Microneedling 60 minutes - $400. S. 00; 3 SkinPen* $1000. 6% Patient Satisfaction based on 146 ratings. Designed to help quickly soothe and calm the skin, the SkinPen Premium Biocellulose Masque is appropriate for all skin tones and types and can be used following. SkinPen is the first and only FDA cleared. Aesthetic Purposes: SkinPen® Precision Microneedling System is also intended to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical. She serves a diverse patient population in the greater Orlando area and often sought out for her second opinion. SkinPen® Precision, by Crown Aesthetics, is the first microneedling device cleared by the U. In as few as three treatments, SkinPen Precision microneedling can improve your complexion, improve the appearance of wrinkles on the neck, and improve the appearance of acne scars to will reveal smooth, healthy skin that glows from within. 8 (12. 13. MicroPen EVO™ SkinPen® Precision System NA . Add to wishlist. 9. 11. ADDISON, Texas (PRWEB) March 06, 2018 -- Bellus Medical, a leader in medical aesthetics products and devices, has been granted clearance and marketing authorization by the FDA for its medical grade microneedling device, SkinPen® Precision, used exclusively by healthcare professionals. Orlando; South Florida; Georgia. Dallas, TX, (March 7, 2023) – Crown Aesthetics, a Crown Laboratories company, is proud to announce that SkinPen® Precision, the microneedling category leader in dermatology and aesthetics, is celebrating its legacy as an award-winning innovation on the 5-year anniversary of becoming the first ever FDA-cleared microneedling device on the market. It’s time to get the beautiful, glowing skin you’ve always wanted. The market arrival of Crown Aesthetics (formerly known as. The quiet medical-grade motor works at speeds of up to 7000rpm which with 14 needles in the cartridge tip, could produce an astonishing 98,000 channels per minute. 13 Oct, 2022, 08:22 ET. Thomas Hitchcock, chief science officer from Crown Laboratories. Schedule Your Appointment. 6,950 likes · 424 talking about this. Traditional Microneedling vs. Powered by state-of-the-art technology, it provides. The tip of the SkinPen contains 12 sterile, disposable micro-needles, and as the pen is gently glided across your skin, it creates “micro-channels. Includes 144 tips. ntended se e SkinPen® Precision sste is a icroneedin deice and accessories intended to e used as a treatent to iroe te aearance o rinkes o te neck or itatrick skin tes and to. New settings will beThe SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. SkinPen® Precision Expands Treatment Offerings with New BSI Certification. REGISTER YOUR INTEREST. Finally, the biggest benefit of RF. Since April 12, Crown Aesthetics has distributed SkinPen into the UK and Ireland market. With the highest level of safety and medical-grade quality, SkinPen precisely delivers thousands of micropunctures to the skin, stimulating the growth of new collagen and. Edited 3/27/2004 3:48 pm ET by JohnW. Stimulates collagen production. THE CROWN AESTHETICS, BELLUS. SkinPen Precision - Face, Neck & Chest + 30 Min Consultation - Bundles of Six treatments. 10 shipping. She guarantees quality and professionalism to all of her customers. So how does SkinPen work? Our therapists use tiny sterile probes to injure the skin on purpose, in a controlled, sterile environment. The SkinPen Precision System is a microneedling device and accessories intended to be used as treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II-IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 and older. Contact us. SkinPen® U. SkinPen Precision FULL FACE. Reg Name To obtain a copy of the winners list, send a self-addressed stamped envelope to Crown Aesthetics, Attn: SkinPen Precision Treatment Package, 5005 LBJ Freeway, Suite 370, Dallas, TX 75244. The average cost of SkinPen treatments is $556, according to 34 reviews from RealSelf members. 3. Crown Aesthetics' SkinPen® Precision Celebrates 5 Year Anniversary as the First FDA-Cleared Microneedling Treatment News provided by. 2 hours 30 minutes @ £630. Read 108 reviews of Microneedling RF to see what real people have to say about their experience, including cost, recovery time & if it was worth it or not. SkinPen. Mona Liza is a passionate patient advocate with a medical background in Internal Medicine, Post-Acute Care, and Clinical Trial Research. Appropriate products will be given to. • Needle depth into the dermis. In fact, it is now the gold standard of microneedling. Treatments were given on day 1, day 30, day 60, and day 90 with follow-up visits atTrade/Device Name: SkinPen® Precision System Regulation Number: 21 CFR 878. Dermapen 4 Microneedling. 24 hours prior to your SkinPen procedure. Includes charging station, training tip, and brochures. Dr. SkinPen® Precision a Crown Laboratories, Inc. Dr. PA live! (WBRE) — Tuesday on PA live!, Rachel spoke with Dr. Skinpen® improves the Skin by using a very fine needle puncturing the top layers of the dermis (skin) hundreds of times. 00 – $ 450. It also improves hyperpigmentation and fine lines. Call Singing River Weight Loss Center to schedule your appointment. 6, 2023 /PRNewswire/ -- Crown Aesthetics, a division of Crown Laboratories, is excited to announce the launch of its new Premium Biocellulose Masque for post-treatment skin soothing. 12. Located in: Little Elm, Texas, United States. SkinPen skin rejuvenation treatments are minimally invasive. [2] ProGen™ intended use: The ProGen PC Kit is indicated for the rapid. If you are looking for a way to refresh your skin without invasive surgery, please contact our team here at Image Perfect Laser in Newport Beach today to discuss how SkinPen microneedling sessions can help you. 00. Stand #AH | Friday 10th March & Saturday 11th. Reg Name . Microneedling SkinPen; Botox / Dysport; Dermal Filler Injections; Microdermabrasion; Radiofrequency; LED Light Therapy (Phototherapy) Skin Tag/Warts Removal; Infrared Light; Treatments. Kellie Girnys, APRN is a board certified Family Nurse Practitioner. The SkinPen® Precision device consists of a microneedling pen handpiece, and a sterile needle cartridge. Returns accepted. SKINPEN ® PRECISION COMPONENTS. [2]Data on file. S. PN#LITINT201215. In this webinar, Dr. $197 and up. T Office Hours Call 1-917-300-0470 For U. Joe Proctor, president of Crown. Call (228) 872-7277 ext. 1 SkinPen ® U. Trade Exhibitions. Thursday 9. Last updated: November 19, 2023. 00. $ 25. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. Safe for all Skin Types: Clinically proven effective on all skin types. 5 mm to obtain pinpoint bleeding. treatment to improve the appearance of facial acneThe SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. Aesthetic Purposes: SkinPen® Precision Microneedling System is also intended to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical. The cost of male enhancement surgery depends on the specific procedures performed. Expect 5-7 days of peeling. The skin stimulates collagen production as part of the healing response. SkinPen Precision Microneedling System. Since it produces more collagen, RF Microneedling fights more intense signs of aging. I’m giving SkinPen a try in an effort to keep the skin on my face. Food and Drug Administration, clinically proven to safely and effectively treat facial acne scars and lines and wrinkles on the neck. She is also experienced in dermaplaning, medical grade chemical peels, customized acne treatment plans, microneedling, pre- and post-operative skin care, and hyperpigmentation disorder treatments. Call 904-990-8484. News provided by. 00. 4. Ho's treatment of choice for a quick skin refresher. This means many thousands of micro-needle columns in the skin, which in turn stimulates the skin to. Clinically shown to safely and effectively treat facial acne scars. SkinPen® Precision ist das weltweit führende Medizinprodukt für Hautremodellierung (Microneedling-Behandlung), das temporäre kleine mikroskopische Kanäle in Ihrer Haut erzeugt. Share to X. 904-664-1552. Aesthetic Purposes:. SkinPen Precision creates controlled micro injuries that stimulate the body’s natural wound healing response which initiates the release of natural. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. If thisAdditional service available. Amy Bradt, RN-BSN is a certified nurse injector who joined Kimiko Medical Aesthetics, the premier spa in Tulsa in 2020 when she won their $7500 makeover earlier that year. RevePeel®. 00(saving $50 and gift). In the United States, SkinPen is clinically proven to improve the appearance of wrinkles on the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. On July 5, 2016, FDA received your De Novo requesting classification of the SkinPen Precision System. SkinPen Precision – Crown Aesthetics $ 1,000. Share this article. 11. Lightweight and quiet design. Eclipse MedCorp LLC The Colony, TX, U. 23 Silver Spring, MD 20993 April 2, 2021 Crown Laboratories, Inc. 6, 2022 /PRNewswire/ -- Crown Aesthetics ("Crown"), a division of Crown. Because our products are regulated, our operations must adhere to Current Good Manufacturing Practice as well as to. Add another layer of protection and peace of mind with THE PEN SLEEVE. SkinPen is the first and only FDA cleared. Aesthetic Purposes: SkinPen® Precision Microneedling System is also intended to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical. SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. . Date: 10/12/2021. Get big results when paired with ProGen PRP. Product Code . Kelly is the best!. Cloudlake Dermatology 400 North Broadway Jericho, NY 11753 • First Few Days: Continue gentle cleansing and moisturizing over the next few days. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. 00. Contemporary. 12. " Amy loves smiling and wants everyone who walks through the doors of KMA to be happy. 5 mm on the neck. SkinPen. Of course the ultimate opinion on safe cutter speed is the cutter head's maker so you should contact them to be sure. SkinPen is not like your skin classic treatment. This simple procedure activates your body’s natural skin-healing power to increase collagen and elastin so your skin returns to a healthier looking and youthful appearance. Book by Practitioner. Couldn’t be happier!On day 4 after my Precision Plus peel I already know I’m going to be so pleased with the results. 510(k) TBD DEN160029 NA . About: SkinPen ® Precision. Company is the first FDA-cleared Microneedling Device. They are at best confusing. Food and Drug Administration, clinically proven to treat facial acne scars safely and effectively for ages 22 and up. SkinPen Precision is the worlds leading skin remodelling (microneedling) medical device that creates temporary small microscopic channels in your skin. SkinPen is designed to improve the appearance of fine lines, wrinkles, and scars on the face and body. / CAN Toll Free Call 1-800-526-8630 For. SkinPen® international intended use: SkinPen Precision is a microneedling device that utilizes collagen induction therapy to treat melasma, acne and surgical scars. / CAN Toll Free Call 1-800-526-8630 For. SkinPen is a microneedling treatment that uses a handheld device to create 1600 tiny punctures in the skin per second. Crown Aesthetics, a division of Crown Laboratories, Inc. CHECK OUT WESH:Stay in the know with the latest Orlando news, weather and sports. 15mL and 30mL processing tubes. Discover more about our recommended pre and post SkinPen treatment instructions to make sure your treatment is as effective as possible. Trade Name . S. $ 140. DALLAS, Oct. SkinPen has passed more than 90 validated. 407. We appreciate your cooperation with our new office safety protocols which you can find here. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017. As an innovative company focused on skin science, Crown will integrate the Eclipse products into the Aesthetics business unit of Crown to complement its SkinPen® Precision and other brands. 1. 5 mm on the neck. SkinPen is FDA- cleared and made in the USA which means it is rigorously tested for safety. 4430 21 CFR Part 878. Holding a Class IIa CE Certification means that the device conforms to the requirements in the Medical Devices Directive, as well as the Medical Devices Regulations. (850) 727-4183. Crown Aesthetics, a division of Crown Laboratories and the global leader in microneedling technology, is proud to announce that SkinPen Precision has again been recognized as an industry best for its superior. Dispositif médical; Le premier dispositif de microponcture homologué par la FDA au monde; Microponcture mécanique : crée des micro-lésions contrôlées pour. 00 – $ 1,350. Powered by state-of-the-art technology, it provides. Was satisfied in all aspects from the first appointment to surgery. 90 Billion in 2021 and is expected to register a revenue CAGR of 11. A. If you opt for it, a topical anesthesia is applied to minimize discomfort. Not only is SkinPen the first FDA-cleared microneedling device, it’s also made in the USA – which means it’s rigorously tested for safety. She is also a recipient of the Hydrafacial Connect Masters scholarship valued at $2000 which is an exclusive, advanced training that only the top Hydrafacialists in. The minimally-invasive in-office procedure. intended use: The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II – IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. See intended use, important safety information, and clinical trial details (data on file) at skinpen. 12 Apr, 2021, 05:03 ET. The Medical Spa Market size was valued at USD 8. Powered by state-of-the-art technology, it provides. 2V Output voltage: 5V. Aesthetic Purposes: SkinPen® Precision Microneedling System is also intended to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical. Add to cart. com to schedule or reschedule an appointment or Virtual. . This healing process works at the site of treatment to remodel the tissue resulting in new collagen and elastin to give your skin a younger, firmer and radiant. Adjust needle depth settings on the SkinPen® Precision cartridge. Контактная. 79%. Bellus Medical, LLC Addison, TX, U. The market arrival of Crown Aesthetics (formerly known as Bellus. She has been practicing in the greater Phoenix area since 2005. WORTH IT. SkinPen Precision is the first-to-market and US FDA-cleared microneedling device clinically proven to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. ”. The SkinPen user manual claims 6300 rpm – 7700 rpm as the "speed" (up to 128 needle punches per second!) but that is mechanically impossible and also would damage the skin, if that were true. Quick View. New settings will be SkinPen Precision is the first FDA-cleared microneedling device on the market, and with over two million treatments performed worldwide, it is the device of choice for over 10,000 aesthetic practices. 3151 Lake Mary, FL BodyView San Ly’s professional profile on LinkedIn. N. 00. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. Power on by pressing and holding the on/off button on the front of SkinPen® Precision for two seconds. CE Mark – Medical device Class II a: Medical Purpose: SkinPen® Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. This in-office treatment also has little to no downtime involved. The UK has taken note on the seriousness of using safe devices to perform microneedling treatments, and many medical directors believe that it is the correct decision.