COOLTOUCH ND: YAG LASER SYSTEM

K030453 · New Star Lasers, Inc. · GEX · May 12, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030453
• Device Name: COOLTOUCH ND: YAG LASER SYSTEM
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolTouch® Nd:YAG Laser System are indicated for the treatment of back acne and the treatment of atrophic acne scars.

Device Story

CoolTouch Nd:YAG Laser System produces 1320nm laser emission; used for treatment of back acne and atrophic acne scars. Device comprises cabinet housing power supply, cooling system, microcontroller, fiber optics, and handpiece. Operated by clinicians in medical settings. Laser energy delivered to target tissue; mechanism involves thermal interaction with skin. Output allows physician to perform dermatological procedures; intended to improve patient skin condition by addressing acne and scarring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; 1320nm wavelength; includes power supply, cooling system, microcontroller, fiber optics, and handpiece. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for treatment of back acne and atrophic acne scars in patients requiring laser surgical intervention.

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

• Candela Smoothbeam™ Laser System (K014128)
• Candela Smoothbeam™ Laser System (K022884)

Submission Summary (Full Text)

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## Section 4 510(K) Summary CoolTouch® Nd:YAG Laser System

MAY 1 2 2003

| Applicant: | New Star Lasers, Inc. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson |
| Telephone / Fax / Email | 916-677-1900 - Phone<br>916-677-1901 - Fax |
| Preparation Date: | February 5, 2003 |
| Device Trade Name: | CoolTouch® Nd:YAG Laser System<br>CoolTouch® II Nd:YAG Laser System |
| Common Name: | Nd:YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-4810 |
| Legally Marketed Predicate Device: | Candela Smoothbeam™ Laser System<br>K014128 for treatment of back acne<br>K022884 for treatment of atrophic acne scars |
| Description of the CoolTouch® Nd:YAG<br>Laser Systems | The CoolTouch® Nd:YAG Laser Systems are ND:YAG<br>lasers producing laser emission at 1320nm. The lasers<br>consist of three interconnected section: The cabinet which<br>houses the power supply, cooling system, microcontroller<br>and the laser, the fiber optics and the handpiece. |
| Intended use of the CoolTouch® Nd:YAG<br>Laser Systems | The CoolTouch® Nd:YAG Laser System are indicated for<br>the treatment of back acne and the treatment of atrophic<br>acne scars. |
| Performance Data: | None |
| Conclusion: | The CoolTouch® Nd:YAG Laser System is substantially<br>equivalent to other existing laser systems in commercial<br>distribution for treatment of back acne and treatment of<br>atrophic acne scars. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAY 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald V. Johnson Vice President, Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747

Re: K030453 Trade/Device Name: CoolTouch Nd:YAG Laser System CoolTouch II Nd: YAG Laser 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: February 11, 2003 Received: February 11, 2003

Dear Mr. Johnson:

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. Donald V. Johnson

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]. 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) you may obtain. 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 vours.

Sincerely yours,

Marki N Millerson

Celia 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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## INDICATION FOR USE STATEMENT

Ka30413 Pending 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch® ND:YAG Laser System

Indications for Use:

The CoolTouch® ND:YAG Laser System is indicated for:

- 1. treatment of back acne
- 2. treatment of atrophic acne scars

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use and the prescription use is selected.