ME

K123845 · Syneron Beauty , Ltd. · ONF · Jan 10, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123845
• Device Name: ME
• Applicant: Syneron Beauty , Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Jan 10, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The me is an over-the-counter device intended for the removal of unwanted hair.

Device Story

mē is an over-the-counter light-based hair removal system; consists of base unit with power supply and handheld applicator with air-cooling. Device utilizes Intense Pulse Light (IPL) (2-4 J/cm²) and low radiofrequency (RF) energy (0.4-0.8 J/cm²). RF signal functions as safety mechanism to ensure skin contact prior to IPL pulse emission. Intended for home use by consumers for unwanted hair removal. Minor updates to electronics, software, and applicator/control panel ergonomics distinguish this version from predicate. Device operation remains unchanged regarding energy source, output, and pulse duration.

Clinical Evidence

Bench testing only. Non-clinical performance testing included electrical safety, electromagnetic compatibility, and software/system verification and validation. Testing confirmed the modified device functions as intended and performs as expected compared to the predicate.

Technological Characteristics

Compact OTC system; base unit and handheld applicator. Energy: IPL (2-4 J/cm²) and RF (0.4-0.8 J/cm²). RF electrodes serve as skin contact sensor. Connectivity: cable-connected applicator. Software: minor updates to electronics/control panel. Sterilization: not specified.

Indications for Use

Indicated for the removal of unwanted hair in the general population via over-the-counter use.

Regulatory Classification

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

• mē (K121598)

Submission Summary (Full Text)

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<123845

#### 510(k) SUMMARY

## JAN 1 0 2013

## Syneron Beauty Ltd.'s mê

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Syneron Beauty Ltd. Kochav Yokneam Bldg. Yokneam Industrial Zone P.O Box 14

Yokneam Illit 20692 Israel

Phone: [phone] Facsimile: [phone]

Contact Person: Omri Hayet

Date Prepared: December 12, 2012

#### Name of Device and Name/Address of Sponsor

mē

## Syneron Beauty Ltd.

Kochav Yokneam Bldg. Yokneam Industrial Zone P.O Box 14 Yokneam Illit 20692 Israel

Common or Usual Name

Light based hair removal system

#### Classification Name

ONF- Laser surgical instrument for use in general and plastic surgery and in dermatology

#### Predicate Devices

mē (K121598)

#### Intended Use / Indications for Use

The me is an over-the counter device intended for the removal of unwanted hair.

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123845
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## 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/cm'), 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. The only changes made in the current version compared to the previously cleared device relate to a minor electronics and software update, and ergonomic enhancements to the applicator and base unit control panel. All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged.

#### Performance Data

The following non-clinical performance testing was conducted to re-validate the updated version of the me device compared against the same test methods and criteria used on the predicate device cleared in K121598.

- Electrical safety .
- Electromagnetic compatibility testing .
- Software verification and validation testing .
- System verification and validation testing ●

In all instances, the modified me device functioned as intended.

#### Substantial Equivalence

The updated model of the me device is as safe and effective as the me (K121598). The modified me device has the same intended uses and same indications as the predicate. The technological characteristics and principles of operation are also very similar to its predicate device. The minor differences in aesthetics, software and electronics between the modified device and its predicate device do not raise any new types of safety or effectiveness questions, as confirmed by software verification and validation, electrical safety, and electromagnetic compatibility/interference testing. No changes in materials resulted from the minor device modifications. Performance data demonstrate that the modified me device performs as expected. Thus, the modified me device is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol for health and well-being.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: January 10, 2013

Syneron Beauty, Limited % Hogan Lovells US, LLP Ms. Janice M. Hogan Regulatory Counsel 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K123845

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: December 13, 2012 Received: December 13, 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, listing 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

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Page 2 - Ms. Janice M. Hogan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/CDRH/CDRHOffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K123845

Device Name: me

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 IF NEEDED)

Neil R Ogden 2013.01.10 10:55:14 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number_

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