SKIN CARE LIGHT

K070870 · Transverse Industries Co. · GEX · Oct 10, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070870
• Device Name: SKIN CARE LIGHT
• Applicant: Transverse Industries Co.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.

Device Story

Skin Care Light is a phototherapy lamp emitting visible blue and/or red light; energy intensity 4, 8, 12mW/cm². Device includes spectral light source, mechanical fixture for adjustable positioning, and electronic control unit. User selects light settings; device features automatic 15-minute shut-off timer. Used for dermatological treatment; intended to provide phototherapeutic light to skin surface. Healthcare provider or patient positions device to expose treatment area; light exposure targets acne vulgaris. Benefits include non-invasive treatment of inflammatory acne.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Visible light therapy device; blue/red spectral output; energy intensity 4, 8, 12mW/cm²; mechanical fixture for adjustable distance/direction; electronic timer with 15-minute auto-shutoff.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris.

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

• ClearLight Phototherapy Device, Model CL 420 (K013623)

Submission Summary (Full Text)

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

## 510(k) Summary as required by section KO70870 807.92(c)

007 ) 0 2007

Submitted by:TRANSVERSE INDUSTRIES CO.

NO.305 HUA CHENG RD.HSIN-CHUANG

CITY TAIPEI,TAIWAN R.O.C.

TEL:[phone]

FAX:[phone]

Contact Person: HO KO LIANG

Prepared On : April 02,2007

K24

- 1 -

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

Classification Name : Laser Instrument,Surgical Powered.

Common or Usual name: Light Therapy Device

Proprietary Name: Skin Care Light

Classification : The subject device satisfies the 21 CFR definition of a class 2

,Laser surgical instrument for use in general and plastic

| Regulation<br>Number | Product Code | Regulation Name | Review<br>Panel |
|----------------------|--------------|--------------------------------------------------------------------------------------------|---------------------------------|
| 878.4810 | GEX | Laser surgical instrument for use<br>in general and plastic surgery and<br>in dermatology. | General &<br>Plastic<br>Surgery |

surgery and in dermatology as follows :

Substantial Equivalence :

Skin Care Light is substantially equivalence with the ClearLight Phototherapy Device,Model CL 420 ( K013623 ) made in Israel.Skin Care Light has the equivalent intended use and different technological characteristics.

Device Description :

Skin Care Light is a lamp intended to treat dermatological conditions by emitting visible light in blue and/or red.The energy intensity are 4,8,12mW/c m².The system includes a spectral band light source and some controlling keys to select light.It also includes

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

mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.

Statement of Indication For Use :

Skin Care Light is intended to provide phototherapeutic light to the body.It is generally indicated to treat dermatological conditions. Skin Care Light is specifically indicated to treat moderate inflammatory acne vulgaris.

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted as a staff with a serpent entwined around it, representing healing and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Transverse Industries Company % Mr. Ho Ko Liang President No. 305 Hua Cheng Road Hsin-Chuang City, Taipei, China (Taiwan)

Re: K070870 Trade/Device Name: Skin Care Light 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: September 18, 2007 Received: September 18, 2007

Dear Mr. Liang:

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.

OCT 1 0 2007

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

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

Page 2 - Mr. Ho Ko Liang

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 begin 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/industry/support/index.html.

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

Enclosure

{5}------------------------------------------------

## Page 3 – Mr. Ho Ko Liang

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. f/t:KSB:kxl:10-04-07

## OC Numbers:

| Division of Enforcement A | 240-276-0115 |
|------------------------------------------------------------|--------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic. Physical Medicine & Anesthesiology Devices Br. | 240-276-0120 |

{6}------------------------------------------------

## Indications for Use

510(k) Number ( if known ) : K070870 Device Name : Skin Care Light Indication For Use :

Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 Subpart D )

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 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 of General, Restorative, and Neurological Devices | |
| 510(k) Number | K020680 |

Page 1 of 1