NLITE SYSTEM

K014130 · Icn Photonics , Ltd. · GEX · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014130
• Device Name: NLITE SYSTEM
• Applicant: Icn Photonics , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of periocular wrinkles.

Device Story

NLite System is a laser surgical instrument; used in dermatology and plastic surgery for treatment of periocular wrinkles. Device delivers laser energy to target tissue; operates via laser-tissue interaction to achieve clinical effect. Used in clinical settings by trained healthcare professionals. Output is laser energy application; intended to improve appearance of periocular wrinkles. Benefits include non-invasive or minimally invasive aesthetic improvement.

Technological Characteristics

Laser surgical instrument; Product Code GEX; Regulation 878.4810; Class II device.

Indications for Use

Indicated for patients requiring treatment of periocular wrinkles in dermatological and plastic surgery applications.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three curved lines that resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2002

Mr. Ian Mortimer Compliance Engineer ICN Photonics Ltd. Units 1 & 2 Heol Rhosyn Parc Dafen Ind.Est. Llanelli, Carmarthenshire, U.K. SA14 8QG

Re: K014130 Trade/Device Name: NLite System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 14, 2001 Received: December 17, 2001

Dear Mr. Mortimer:

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 - Mr. Ian Mortimer

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Atyt Rhodes
Celia M. Witten, Ph.D., M.D.

M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 5. I idications for Use Statement

51() k) Number (if known): K014130

Device Name: NLite System

Indi :ations for Use:

The NLite System is indicated for use in Dermatological and Plastic Sur ery applications and this device is intended for use in the trea ment of periocular wrinkles.

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 | K014130 |
|---------------------------------------|-------------------------|
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |

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Confidential