Mini me

K143339 · Iluminage Ltd.(Formerly Syneron Beauty Ltd.) · ONF · Dec 19, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K143339
• Device Name: Mini me
• Applicant: Iluminage Ltd.(Formerly Syneron Beauty Ltd.)
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mini mē is an over-the counter device intended for the removal of unwanted hair. The Mini mē is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

Device Story

Mini mē is a handheld, over-the-counter light-based hair removal system; intended for home use. Device utilizes Intense Pulsed Light (IPL) technology to target hair follicles; energy output up to 4 J/cm². Includes integrated skin contact sensor using low RF energy signal to ensure proper contact before pulse emission. Powered by external supply; includes cooling fan for safety. User operates device by applying to skin; light pulses inhibit hair growth. Provides permanent hair reduction over treatment regimen. Benefits include convenient, at-home hair removal. Substantially equivalent to predicate mē System (K131649) with minor hardware/dimension modifications.

Clinical Evidence

Bench testing only. No clinical data presented. Non-clinical performance testing included electrical safety, electromagnetic compatibility, software verification/validation, and system verification/validation, confirming the device functions as intended and meets the same criteria as the predicate device.

Technological Characteristics

Handheld IPL device; external power supply. Delivers IPL up to 4 J/cm². Features skin contact sensor using low RF energy signal. Includes cooling fan. Dimensions modified from predicate; core technology and output specifications identical to K131649.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair growth in general population.

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 System (K131649)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 19, 2014

Iluminage Ltd. (Formerly Syneron Beauty Ltd.) % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K143339

Trade/Device Name: Mini 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: November 20, 2014 Received: November 20, 2014

Dear Ms. Janice M. 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

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S.Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known): K143339

Device Name: Mini me

Indications for Use (Describe)

The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

XX Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

{3}------------------------------------------------

## 510(k) SUMMARY

#### Iluminage Ltd.'s Mini mē

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

## Iluminage Ltd.

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

Phone: [phone] X 202 Facsimile: [phone]

Contact Person: Bobae Kim

Date Prepared: November 20, 2014

## Name of Device and Name/Address of Sponsor

## Mini mē

#### Iluminage 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

Iluminage Ltd's (Formerly Syneron Beauty Ltd)- Mē System (K131649)

## Intended Use / Indications for Use

The Mini mē is an over-the counter device intended for the removal of unwanted hair. Mini mē is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

{4}------------------------------------------------

# Technological Characteristics

The Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse. These essential output specifications remain unchanged from the cleared predicate device (K131649).

# Performance Data

Risk analysis was performed to assess the modifications to the Mini me device, and confirmed that no new risks have been raised. The following non-clinical performance testing was conducted to re-validate the modified device, against the same test methods and criteria used on the predicate device cleared in K131469 that includes:

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

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

# Substantial Equivalence

The Mini mē is as safe and effective as the predicate device, the mē System (K131649). The Mini me uses the same technology and wavelength of light and has the same intended and indications for use and principle of operation as the predicate device. The main safety features that include the skin contact sensor and cooling fan in the predicate device are also preserved in the Mini mē. Furthermore, the Mini mē delivers energy within the same limits as the predicate device including the rate and duration of each pulse emission and therefore no new questions of efficacy are raised in the modified device. Any minor differences in the dimensions and hardware of the Mini me device compared to its predicate device do not raise new issues of safety or effectiveness in the modified Mini mē device. Verification and validation testing demonstrated that the Mini me System is as safe and effective as the me System (K131649). There were no new hazards identified as a result of these minor modifications and therefore the Mini mē System is substantially equivalent.