GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE

K062991 · Light Bioscience, LLC · OHS · Feb 15, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K062991
• Device Name: GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
• Applicant: Light Bioscience, LLC
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Feb 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.

Device Story

Hand-held LED photomodulation device; utilizes low-intensity light-emitting diode (LED) lamp to deliver light energy to skin. Device features LED array, lens, handpiece, circuit boards, and power supply. Designed for over-the-counter (OTC) home use by consumers. User places device in contact with skin at fixed distance determined by lens cover. Photomodulation principle intended to treat periorbital wrinkles and rhytides. Device provides non-thermal light exposure; no complex clinical decision-making or output interpretation required by user.

Clinical Evidence

Bench testing confirmed no significant difference in spectral content compared to the predicate device (K031425). A user study was conducted to confirm that lay users could operate the device in accordance with the provided instructions.

Technological Characteristics

Hand-held device; low-intensity LED array; lens cover for fixed-distance skin contact; includes handpiece, three circuit boards, and power supply. Non-thermal light emission. Standalone operation.

Indications for Use

Indicated for over-the-counter treatment of periorbital wrinkles and rhytides in the 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

• GentleWaves LED Photomodulation System (K031425)

Submission Summary (Full Text)

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

# 510(k) SUMMARY

# Light BioSciences, LLC's

# GentleWaves Consumer LED Photomodulation Device (K062991)

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

Light BioScience, LLC 933 First Colonial Road, Suite 204 Virginia Beach, Virginia 23454

[phone] Phone: Facsimile: [phone]

[5]] 15 [2

Richard Krupnick Contact Person:

Date Prepared: September 29, 2006

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

GentleWaves Consumer LED Photomodulation Device

Light BioScience, LLC 933 First Colonial Road, Suite 204 Virginia Beach, Virginia 23454

## Common or Usual Name

Lamp, nonheating

## Classification Name

Surgical powered laser instrument

## Predicate Devices

Light BioScience, LLC's GentleWaves LED Photomodulation System (K031425)

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

## Intended Use / Indications for Use

The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.

#### Technological Characteristics

The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.

#### Performance Data

Performance testing of the GentleWaves Consumer demonstrates no significant difference in spectral content as compared to the cleared GentleWaves device (K031425). Thus, performance and safety testing obtained for the cleared GentleWaves is fully applicable to the GentleWaves Consumer. In addition, a user study was performed to confirm that lay users were able to use the GentleWaves Consumer in accordance with its instructions for use.

#### Substantial Equivalence

The GentleWaves Consumer is as safe and effective as the GentleWaves LED Photomodulation System. The GentleWaves Consumer has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the GentleWaves Consumer and its predicate device raise no new issues of safety or effectiveness. In addition, the difference in indication as an OTC device does not affect the device's therapeutic effect. Thus, the GentleWave Consumer is substantially equivalent.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The logo is black and white.

**AUG 18 2008**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Light Bioscience, L.L.C. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan 555 Thirteenth Street Northwest Washington, District of Columbia 20004

Re: K062991

Trade/Device Name: Gentlewaves™ Consumer LED Photomodulation Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHS Dated: February 15, 2008 Received: February 15, 2008

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of June 26, 2008.

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 (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.

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); good manufacturing practice requirements as set

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

Page 2 - Mr. Jonathan S. Kahan

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

**Sincerely yours,**

Mark A. Milker

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

#### Indications for Use Statement

510(k) Number (if known): K062991

Device Name: GentleWaves Consumer LED Photomodulation Device

Indications for Use:

The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.

Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_X_ (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerman

(Division Sign-Off) (Division Sign-on) Restorative,
Division of General, Restorative, Division of Cological Devices

510(k) Number K06294

_ of Page

3