COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II

K022817 · Icn Pharmaceuticals, Inc. · GEX · Nov 22, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022817
• Device Name: COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
• Applicant: Icn Pharmaceuticals, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 22, 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 use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.

Device Story

CoolTouch Nd:YAG Laser System emits 1320 nm laser energy for dermatological and plastic surgery procedures. Device comprises three interconnected sections: cabinet (housing power supply, cooling system, microcontroller, and laser source), fiber optic delivery system, and handpiece. Operated by clinicians in clinical settings. Laser energy targets tissue to treat fine lines and wrinkles. System utilizes a microcontroller for operational control. Clinical benefit includes reduction of periorbital and perioral wrinkles.

Clinical Evidence

Clinical trials indicated effectiveness in treating periorbital and perioral wrinkles. Results referenced from previous related 510(k) submissions.

Technological Characteristics

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

Indications for Use

Indicated for dermatological and plastic surgery applications, specifically the treatment of fine lines and wrinkles in adult 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

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

Submission Summary (Full Text)

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022817

## ICN Pharmaceuticals, Inc. CoolTouch Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY

NOV 2222002

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| Submitter: | ICN Pharmaceuticals, Inc. |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 3300 Hyland Ave.<br>Costa Mesa, CA 92626 |
| Contact Person: | Edward F. Smith III<br>Director, Corporate Regulatory Affairs |
| Telephone: | [phone] X 2016 |
| Facsimile: | [phone] |
| Date Prepared: | August 22, 2002 |
| 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 optic, and the<br>handpiece. |
| Intended use of CoolTouch<br>Nd: Y AG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are indicated<br>for use in Dermatological and Plastic Surgery<br>applications including use in the treatment of fine lines<br>and wrinkles. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical trials produced results that indicated that the<br>CoolTouch Nd:YAG Laser Systems are effective in the<br>treatment of periorbital and perioral wrinkles. See<br>previous related 510(k) submissions for clinical results. |
| Conclusion: | The CoolTouch Nd: YAG Laser Systems are indicated |

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for the general treatment of wrinkles.

# Additional Information:

.

None requested at this time

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpent and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

200 Corporate Boulevaro Rockville MD 20850

ICN Pharmaceuticals, Inc. Dr. Edward F. Smith III Director, Corporate Regulatory Affairs 3300 Hyland Avenue Costa Mesa, California 92626

Re: K022817

Trade/Device Name: CoolTouch Nd: YAG and CoolTouch II Nd: YAG Laser Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: August 22, 2002 Received: August 26, 2002

Dear Dr. Smith:

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

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Page 2 – Dr. Edward F. Smith

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]. 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 vours.

Miriam C. Provost

( Celia M. Witten, Ph.D., MD 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 STATEME

510(k) Number: K022817

Device Name: ICN Pharmaceuticals, Inc. "CoolTouch" and "CoolTouch-II" Nd: YAG Laser Systems

Indications for Use:

The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

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

210(K) N Prescription Use 1 Over-the-Counter Use (per 21 CFR 801.109)