COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM

K040131 · New Star Lasers, Inc. · GEX · Apr 20, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040131
• Device Name: COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CooTouch® Nd:YAG Laser System are indicated for the treatment of mild to moderate inflammatory acne vulgaris.

Device Story

CoolTouch Nd:YAG Laser Systems (CoolTouch, CoolTouch II, CoolTouch CT3) are pulsed surgical lasers emitting at 1320nm. Device consists of a cabinet housing power supply, cooling system, and microcontroller; fiber optics; and a handpiece. Used by clinicians for treatment of mild to moderate inflammatory acne vulgaris. Laser energy is delivered to the target tissue to achieve therapeutic effect. System operation is managed via integrated microcontroller.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; 1320nm wavelength; pulsed emission. Components include cabinet (power supply, cooling system, microcontroller), fiber optics, and handpiece. Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for the treatment of mild to moderate inflammatory acne vulgaris in patients.

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 (K030834)

Submission Summary (Full Text)

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## Section 4

K 040131

:

| Applicant: | New Star Lasers, Inc. |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson |
| Telephone / Fax / Email | 916-677-1912 - Phone<br>916-677-1901 - Fax |
| Preparation Date: | January 14, 2004 |
| Device Trade Name: | CoolTouch® Nd:YAG Laser System<br>CoolTouch® II Nd:YAG Laser System<br>CoolTouch® CT3 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>K030834 Treatment of mild to moderate inflammatory acne<br>vulgaris. |
| Description of the CoolTouch® Nd: Y AG<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: a) The cabinet, which<br>houses the power supply, cooling system , microcontroler<br>and the laser, b) the fiber optics and c) the handpiece. |
| Intended use of the CoolTouch® Nd:YAG<br>Laser Systems | The CooTouch® Nd:YAG Laser System are indicated for<br>the treatment of mild to moderate inflammatory acne<br>vulgaris. |
| 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 mild to moderate inflammatory<br>acne vulgaris. |

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2004

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

Re: K040131

K040131
Trade/Device Name: CoolTouch® Nd:YAG Laser System, CoolTouch® II Nd:YAG Laser System, CoolTouch® CT3 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: January 16, 2004 Received: January 21, 2004

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars mannent date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the enasurance with the provisions of the Federal Food, Drug, devices that have tech recatismed in acceraal of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise the general controls provisions of the Act. The r ou may, merciole, manel alle act include requirements for annual registration, listing of general controls provisions of the tice, 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 II your device is classified (see above) into existing major regulations affecting your device can may be subject to such additional controller 1. Misting the 1. John 898. In addition, FDA may be found in the Code of Feaster regerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial cquivalence determination docs not mean Please be advised that I Dri 3 issuance of a sudevice complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I edical statutes and regarations and uding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fatt 607), labeling (21 CFR Part 820); and If applicable, the electronic form in the quality systems (Scctions 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) i his letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notheadon: "The PDF mining of castion 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 acritories - 301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Compulation in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Coness http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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## Section 3

## INDICATION FOR USE STATEMENT

510(k) Number: Pending < K040131

Device Name: CoolTouch®, CoolTouch® II, and CoolTouch® CT3 ND:YAG Laser Systems

Indications for Use:

II, and CoolTouch® CT3 The CoolTouch®, CoolTouch® ND:YAG Laser Systems are indicated for the treatment of mild to moderate inflammatory acne vulgaris.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C

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

K640131 510(k) Number_ Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use (per 21 CFR 801.109)