COOLTOUCH, MODEL NS 160

K040921 · Cooltouch, Inc. · GEX · Sep 28, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040921
• Device Name: COOLTOUCH, MODEL NS 160
• Applicant: Cooltouch, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

Device Story

CoolTouch NS-160 is an Nd:YAG surgical laser system emitting at 1320 nm. Device comprises a cabinet housing power supply, cooling system, microcontroller, and laser source, connected to a fiber optic delivery system. Used by physicians in clinical settings for endovenous laser treatment of greater saphenous vein reflux. Laser energy is delivered via fiber optic to the target vein; thermal energy induces vein closure. Output allows clinicians to treat varicose veins and varicosities minimally invasively, potentially reducing patient recovery time compared to traditional surgical stripping.

Clinical Evidence

Clinical data indicated the system is effective for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities. No specific sample sizes or statistical metrics were provided in the summary.

Technological Characteristics

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

Indications for Use

Indicated for patients with reflux of the greater 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

• Diomed 810nm Surgical Laser (K023543, K012398)
• Biolitec Ceralas D10-60 810nm Diode Laser (K030700)
• Biolitec Ceralas D 980nm Diode Laser (K024088)

Submission Summary (Full Text)

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## SEP 2 8 2004

## CoolTouch Inc. CoolTouch NS-160 Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY

KO4 0421

This 510(k) summary of safety and effectiveness for the CoolTouch NS-160 Nd:YAG Laser System is submitted in accordance with the requirements of SMDA of 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | CoolTouch Inc. |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson<br>Vice-President of Operations |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date Prepared: | April 6. 2004 |
| Device Trade Name: | CoolTouch Model NS-160 Nd:YAG Laser System |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.<br>21 C.F.R. § 878.4810 |
| Legally Marketed Predicate Device: | Diomed 810nm Surgical Laser, K023543, K012398<br>Biolitec Ceralas D10-60 810nm Diode Laser, K030700<br>Biolitec Ceralas D 980nm Diode Laser, K024088 |
| Description of the CoolTouch<br>Nd:YAG Laser Systems: | The CoolTouch NS-160 Nd:YAG Laser System is an<br>ND:YAG laser producing laser emission at 1320 nm.<br>The laser consists of two sections: The cabinet, which<br>houses the power supply, cooling system,<br>microcontroller and the laser, and the fiber optic. |
| Intended use of CoolTouch<br>Nd:YAG Laser Systems: | The CoolTouch NS-160 Nd: Y AG Laser System is<br>indicated for the treatment of reflux of the greater<br>saphenous vein associated with varicose veins and<br>varicosities. |
| Nonclinical Performance Data: | None |

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| Clinical Performance Data: | Clinical data produced results that indicate that the<br>CoolTouch Nd:YAG Laser System is effective in the<br>treatment of reflux of the greater saphenous vein<br>associated with varicose veins and varicosities. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The CoolTouch NS-160 Laser System is indicated for<br>the treatment of reflux of the greater saphenous vein<br>associated with varicose veins and varicosities. The<br>CoolTouch NS-160 is substantially equivalent to the<br>predicate devices with the same intended use. |
| Additional Information: | None requested at this time |

.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2004

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

Re: K040921

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: August 16, 2004 Received: August 19, 2004

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]. 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 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

K040921 510(k) Number:

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

Indications for Use:

The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater 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)

Muriam C. Provost

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

Prescription Use **510(k) Number** OR K640921 Over-the-Counter Use
(per 21 CFR 801.109)