COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV

K051434 · New Star Lasers, Inc. · GEX · Aug 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051434
• Device Name: COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

In addition to previously cleared indications for use, the CoolTouch CTEV and CT3S Nd:YAG Laser Systems are indicated for the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.

Device Story

CoolTouch CTEV and CT3S are Nd:YAG laser systems emitting 1320 nm wavelength; used for endovenous treatment of small saphenous vein reflux. System comprises cabinet housing power supply, cooling system, microcontroller, and laser; connected to fiber optic and handpiece. Operated by clinicians in clinical settings. Laser energy delivered via fiber optic to target vein; thermal effect induces vein closure. Benefits include minimally invasive treatment of varicose veins/varicosities.

Clinical Evidence

Clinical results were submitted demonstrating the effectiveness of the CoolTouch Nd:YAG Laser Systems in treating reflux of the small saphenous vein associated with varicose veins and varicosities.

Technological Characteristics

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

Indications for Use

Indicated for patients with reflux of the small saphenous vein associated with varicose veins and varicosities.

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

• CoolTouch Inc. Model NS-160 (CTEV) (K051434)
• CT3S Nd:YAG Laser Systems (K051434)

Submission Summary (Full Text)

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## AUG 9 - 2005

## CoolTouch Incorporated Model CTEV and CT3S Nd:YAG Laser Systems 510(k) Premarket Notification 510(k) SUMMARY

K051434

| Submitter: | CoolTouch Incorporated |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson<br>Vice-President of Operations |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date Prepared: | May 31, 2005 |
| Device Trade Name: | CoolTouch Corporation Models CTEV and CT3S<br>Nd:YAG Laser Systems |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.<br>21 C.F.R. § 878.4810 |
| Legally Marketed Predicate<br>Devices: | CoolTouch Inc. Model NS-160 (CTEV).and CT3S<br>Nd:YAG Laser Systems |
| 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/or the<br>handpiece. |
| Intended use of CoolTouch<br>Nd:YAG Laser Systems: | In addition to already cleared indications, the intended<br>use of the CoolTouch CTEV and CT3S Nd:YAG Laser<br>Systems is:<br>for treatment of reflux of the small saphenous vein<br>associated with varicose veins and varicosities. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical results were submitted that indicate that the<br>CoolTouch Nd:YAG Laser Systems are effective in the<br>treatment of reflux of the small saphenous vein<br>associated with varicose veins and varicosities. |
| Conclusion: | In addition to previously cleared indications, the<br>CoolTouch CTEV and CT3S Nd:YAG Laser Systems<br>are indicated:<br>for treatment of reflux of the small saphenous vein<br>associated with varicose veins and varicosities. |
| Additional Information: | None requested at this time |

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Image /page/2/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 lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 9 - 2005

Mr. Donald V. Johnson Vice-President, Operations CoolTouch Corporation 9085 Foothills Boulevard Roseville, California 95747

Re: K051434 Trade/Device Name: CoolTouch NS-160 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: May 31, 2005 Received: June 1, 2005

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & no rowe 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) This iciter with anow you to ought mading of substantial equivalence of your device to a legally prematication. The PDF miaing of castification 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 11 you desire specific acrioliance at [phone]. Also, please note the regulation entitled, Comacs the Office of Comphanes an (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vo

Barbara Barchus
for

Mark N. Melkerson Acting 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 051434 510(k) Number:

Device Name: CoolTouch NS-160 Nd: YAG Laser System

Indications for Use:

In addition to previously cleared indications for use, the CoolTouch CTEV and CT3S Nd:YAG Laser Systems are indicated for the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use |> (per 21 CFR 801.109)

OR Over-the-Counter Use *_*_
Sharbara mnhus
(Division Sign-Off)

Sivision of General, Restorative and Neurological Devices

510(k) Number K051434