COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS

K014035 · Cooltouch Corp. · GEX · Mar 7, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014035
• Device Name: COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
• Applicant: Cooltouch Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.

Device Story

CoolTouch Nd:YAG Laser System emits 1320 nm laser energy for treatment of periorbital and perioral wrinkles. Device comprises cabinet housing power supply, cooling system, microcontroller, laser source, fiber optics, and handpiece. Operated by clinicians in professional settings. Laser energy delivery targets skin tissue to address wrinkles. Clinical benefit derived from laser-tissue interaction.

Clinical Evidence

Clinical trials indicated the CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles.

Technological Characteristics

Pulsed Nd:YAG laser system; 1320 nm emission wavelength; includes cabinet, power supply, cooling system, microcontroller, fiber optics, and handpiece.

Indications for Use

Indicated for patients requiring treatment of periorbital and perioral wrinkles.

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

• New Star Lasers, Inc. Model 130 Nd:YAG Surgical Laser System (K962791)

Submission Summary (Full Text)

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| MAR 7 2002 | CoolTouch Corporation<br>CoolTouch Nd:YAG Laser System<br>510(k) Premarket Notification |
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| 510(k) SUMMARY | |
| Submitter: | CoolTouch Corporation |
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson<br>Director of Regulatory and Quality Affairs |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date Prepared: | December 6, 2001 |
| Device Trade Name: | CoolTouch Nd:YAG Laser System<br>CoolTouch-II Nd:YAG Laser System |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Laser Surgical Instrument.<br>21 C.F.R. § 878.4810 |
| Legally Marketed Predicate Device: | New Star Lasers, Inc. Model 130 Nd:YAG Surgical<br>Laser System (K962791). |
| Description of the CoolTouch<br>Nd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are ND:YAG<br>lasers producing laser emission at 1320 nm. The lasers<br>consist of three interconnected sections: The cabinet,<br>which houses the power supply, cooling system,<br>microcontroller and the laser, the fiber optics, and the<br>handpiece. |
| Intended use of CoolTouch<br>Nd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are indicated<br>for the treatment of periorbital and perioral wrinkles. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical trials produced results that indicate that that<br>CoolTouch Nd:YAG Laser System is effective in the<br>treatment of periorbital and perioral wrinkles. |
| Conclusion: | The CoolTouch Nd:YAG Laser Systems are indicated<br>for the treatment of periorbital and perioral wrinkles. |
| Additional Information: | None requested at this time |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 7 2002

Mr. Donald V. Johnson Director of Regulatory and Quality Affairs CoolTouch Corporation 9085 Foothills Boulevard Roseville, CA 95747

Re: K014035

Trade/Device Name: Cooltouch Nd: YAG Laser System CoolTouch-II Nd:YAG Laser 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 6, 2001 Received: December 7, 2001

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaren on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass suated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to may 20, 1978, are cance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, therefere, mains of the Act include requirements for annual registration, listing of general controll provision 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 If your device is olassified (600 wor of ols. Existing major regulations affecting your device can may be subject to such additions, 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 r lease or admissed a determination that your device complies with other requirements of the Act that I Dr Has made a statutes and regulations administered by other Federal agencies. You must of any I oderal bather act's requirements, including, but not limited to: registration and listing (21 compry with an the riev 61 CFR Part 801); good manufacturing practice requirements as set Of It Fat 607), accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sichine (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 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,

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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## INDICATION FOR USE STATEMENT

K 014035 510(k) Number: __

Device Name: CoolTouch Corporation "CoolTouch"and "CoolTouch-II" Nd:YAG Laser Systems

Indications for Use:

The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (per 21 CFR 801.109)

OR

Over-the-Counter Use_

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K6/4035