← Product Code [ONF](/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF) · K121598 # ME HAIR2GO (K121598) _Syneron Medical, Ltd. · ONF · Oct 12, 2012 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K121598 ## Device Facts - **Applicant:** Syneron Medical, Ltd. - **Product Code:** [ONF](/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF.md) - **Decision Date:** Oct 12, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The me is an over-the counter device intended for the removal of unwanted hair. ## Device Story The mē is a compact, over-the-counter hair removal system consisting of a base unit and a handheld applicator with air-cooling. It utilizes Intense Pulsed Light (IPL) (2-4 J/cm2) for hair removal and low-level Radio Frequency (RF) energy (0.4-0.8 J/cm2) delivered via electrodes. The RF signal functions as a safety mechanism to confirm skin contact before the IPL pulse is emitted. Designed for home use by consumers, the device is operated by the user to treat unwanted hair. The healthcare provider does not directly operate the device; however, clinical studies confirmed that users, including those with low literacy, can comprehend labeling and operate the device safely. The device provides a non-professional method for hair clearance, potentially offering long-term hair reduction benefits to the patient. ## Clinical Evidence Clinical evidence includes an 87-patient multi-center study in a simulated home-use setting demonstrating significant hair clearance across skin types I-VI. A 37-patient study under extreme overuse conditions confirmed safety with no adverse events. A label comprehension (n=63) and usability study (n=46) confirmed that consumers, including low-literacy individuals, could safely operate the device and understand contraindications. ## Technological Characteristics Compact system with base unit and handheld applicator. Employs Intense Pulsed Light (IPL) (2-4 J/cm2) and Radio Frequency (RF) (0.4-0.8 J/cm2). RF electrodes serve as a skin-contact safety sensor. Includes air-cooling system. Biocompatibility testing performed for cytotoxicity, irritation, and sensitization. Electrical safety and electromagnetic compatibility testing conducted. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - Home Skinovations Ltd.'s Silk'n Flash N'Go ([K082298](/device/K082298.md); [K103184](/device/K103184.md)) - Shaser IPL Hair Removal System ([K103560](/device/K103560.md)) - Spectragenics, Inc.'s Tria Laser Hair Removal System ([K090820](/device/K090820.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 1121598 Page 1 of 3 ## 510(k) SUMMARY OCT 1 2 2012 #### Syneron Medical Ltd.'s me Device Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Syneron Medical Ltd. P.O.B. 550 Industrial Zone Tavor Building Yokneam Illit, 20692 Israel Phone: +972-4-9098-700 Facsimile: +972-4-9098-701 Contact Person: Omri Hayet, Chief Operating Officer, Syneron Beauty Date Prepared: May 30, 2012 Name of Device mē Common or Usual Name Light based hair removal system Classification Name GEX #### Predicate Devices Home Skinovations Ltd.'s Silk'n Flash N'Go (K082298; K103184) Shaser IPL Hair Removal System (K103560) Spectragenics, Inc.'s Tria Laser Hair Removal System (K090820) #### Intended Use / Indications for Use The me is an over-the counter device intended for the removal of unwanted hair. {1}------------------------------------------------ $$\xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi \circ \xi$$ ## Technological Characteristics The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm2), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm2) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted. ### Performance Data The following nonclinical performance testing was conducted to support the substantial equivalence of the me: - . electrical safety - electromagnetic compatibility testing . - optical radiation safety . - device integrity testing (packaging/transport) . - biocompatibility testing for cytotoxicity, irritation and skin sensitization . - software verification and validation testing, and . - testing to characterize both the external device temperature at the skin interface . and the resultant temperature increase in the skin. The following clinical testing was conducted to support the safety and efficacy of the me: - Efficacy and safety study under the intended conditions of use: . - O An 87-patient multi-center (4 sites) clinical study to demonstrate effective use of the device, in a simulated home-use setting. - The study evaluated the efficacy of the mē hair removal device at 1 and 3 months o after the final basic (7th) treatment and compared the extent of hair removal with 3 additional monthly maintenance treatments vs. without the 3 additional monthly maintenance treatments. - Significant hair clearance was achieved for all skin types groups (skin type I-VI), o even without the monthly maintenance treatments. - Dedicated study, under extreme conditions of overuse, to confirm safety: . - o A 37-patient clinical study to establish safety with a treatment protocol that simulated frequent (over) use of the device. - The study included participants with Fitzpatrick skin types (II-VI); each patient o received treatment on at least 2 anatomical sites, each of which was treated {2}------------------------------------------------ 121598 Page 30f3 bilaterally, for a total of at least 4 sites per subject. The results showed no adverse events even under overuse conditions. - Label comprehension and usability study to test consumers' ability to understand . the instructions for use including contraindications and to evaluate their ability to use the device safety in simulated home use conditions. - 63 participated in the label comprehension study and 46 subjects o participated in the usability testing. These included low literacy participants. The results confirmed adequate label comprehension and correct device use in an OTC environment. All of these tests confirmed that the me performs as intended. #### Substantial Equivalence The me is substantially equivalent to the Home Skinovations Ltd. Silk'n Flash N'Go (K082298; K103184), the Shaser IPL System (K103560), and the Spectragenics, Inc. Tria Laser Hair Removal System (K090820). The me has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the me and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that these minor differences do not adversely impact performance of the device for its intended use. Thus, the me is substantially equivalent. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 1 2 2012 Syneron Medical. Limited % Hogan Lovells US LLP Ms. Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103 Re: K121598 Trade/Device Name: mē Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: September 24, 2012 Received: September 24, 2012 Dear Ms. Hogan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {4}------------------------------------------------ ## Page 2 - Ms. Janice M. Hogan device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, son Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health 4// Enclosure {5}------------------------------------------------ #### Indications for Use Statement 510(k) Number (if known): k121598 Device Name: mē Indications for Use: The me is an over-the counter device intended for the removal of unwanted hair. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) · El Keith (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K121598 Page ___ of ___ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K121598](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONF/K121598) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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