REVLIGHT SKIN CARE SYSTEM

K042630 · Skincare Technology, Inc. · GEX · Jun 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K042630
• Device Name: REVLIGHT SKIN CARE SYSTEM
• Applicant: Skincare Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

RevLight is intended for use to provide LED light to the body, and with the large pulsators, facial massage. Depending on the wavelength(s) of light delivered by the detachable Pulsators that are connected to the base unit, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).

Device Story

RevLight Skincare System utilizes LED phototherapy to deliver light (420-940nm) to skin. System comprises base unit (power/control) and detachable Pulsators. Pulsators moved over skin surface by user/clinician. Blue light treats moderate inflammatory acne vulgaris; Amber/Red light provides topical heating for blood flow, muscle relaxation, and pain relief. Large pulsators provide mechanical facial massage. Device intended for dermatological applications; provides therapeutic benefits via light-tissue interaction and mechanical stimulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

LED-based phototherapy system; output range 420-940nm. Base unit contains power supply and control electronics. Detachable Pulsators for light delivery and mechanical massage. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris (Blue Pulsators) or patients requiring topical heating for increased blood flow, muscle relaxation, and pain relief (Amber/Red Pulsators). Includes facial massage capability with large pulsators.

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

• Super Nova/Acubeam (K001179)
• OmniLux Blue (K030883)
• Revive (OmniLux Red) (K030426)
• ClearLight (K013623)
• Aurora SR (K022266;K033946(supp))
• Lovely I (K033946)
• Soundskin Phototherapy System (K040103)
• Model HM-45 (K9354597)

Submission Summary (Full Text)

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## 510(k) Summary, K042630

| Applicant | Skincare Technology Inc.<br>119 W. Hubbard St.<br>Suite 300<br>Chicago, IL 60610 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | June 8, 2005 |
| Device Name | RevLight® Skincare System |
| Common Name | LED phototherapy |
| Classification name | Laser Instrument, Surgical Powered<br>Procode: GEX |
| Summary of Substantial<br>Equivalence | RevLight® is substantially equivalent in respect to the intended<br>use, design and method of operation to numerous cleared devices,<br>including:<br>Product /510(k)<br>LED Systems<br>Super Nova/Acubeam (K001179)<br>OmniLux Blue (K030883)<br>Revive (OmniLux Red) (K030426)<br>ClearLight (K013623)<br>Aurora SR (K022266;K033946(supp))<br>Lovely I (K033946)<br>Soundskin Phototherapy System (K040103)<br>Massagers<br>Model HM-45 (K9354597) |
| Device Description | RevLight is a device that utilizes Light Emitting Diodes to provide<br>LED light to the body. The base unit contains the power supplies<br>and the control unit. Attachable to the base unit are three sets of<br>Pulsators that deliver the light to the skin as they are moved over<br>the skin surface. The output of the Pulsators ranges from 420-<br>940nm. |
| Intended Use and<br>Indications | RevLight is intended for use to provide LED light to the body, and<br>with the large pulsators, facial massage. Depending on the<br>wavelength(s) of light delivered by the detachable Pulsators that<br>are connected to the base unit, RevLight is:<br>1. generally indicated to treat dermatological conditions and<br>specifically indicated to treat moderate inflammatory acne<br>vulgaris (Blue Pulsators); and<br>generally indicated to provide topical heating to promote<br>increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators). |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Erri-

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 2005

Skincare Technologies Incorporated C/o Richard O. Wood Bell, Boyd & Lloyd, LLC 70 West Madison Street, Suite 3300 Chicago, Illinois 60602-4207

Re: K042630

Trade/Device Name: RevLight® Skin Care System 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: GEX Dated: May 12, 2005 Received: May 13, 2005

Dear Mr. Wood:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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.

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Page 2 – Richard O. Wood

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin matically of substantial equivalence of your device to a legally promatics notification. "The aclassification 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 If you desire specific arrive ior your and [phone] . Also, please note the regulation entitled, Colliact the Office of Compuner as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Prevost, RN

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K042630_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

| Device Name: | RevLight® Skin Care System |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use (Large<br>and Small Pulsators) | RevLight is intended for use to provide LED light to the<br>body. |
| Indications for Use (Large<br>Pulsators) | Facial massage. |
| Blue Pulsators | Used with the RevLight, are generally indicated to treat<br>dermatological conditions and specifically indicated to treat<br>moderate inflammatory acne vulgaris. |
| Amber Pulsators | Used with the RevLight, are generally indicated to provide<br>topical heating to promote increased blood flow, for<br>temporary relaxation of muscle and relief of pain. |
| Red Pulsators | Used with the RevLight, are generally indicated to provide<br>topical heating to promote increased blood flow, for<br>temporary relaxation of muscle and relief of pain. |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K042630

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