COOLTOUCH, MODEL CTEV

K061618 · New Star Lasers, Inc. · GEX · Sep 25, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061618
• Device Name: COOLTOUCH, MODEL CTEV
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.

Device Story

The CoolTouch CTEV Nd:YAG Laser System is a surgical laser device emitting at 1320 nm. The system comprises a cabinet housing a power supply, cooling system, microcontroller, and laser source, along with a fiber optic delivery system, footswitch, and fiber optic pull-back device. It is intended for use by clinicians in a medical setting to treat superficial incompetent tributary veins. The laser energy is delivered via fiber optic to the target vein to induce thermal effects. The clinician operates the system to perform the procedure, which aims to treat vein reflux associated with varicose veins and varicosities, potentially improving patient symptoms and venous health.

Clinical Evidence

Clinical results were submitted indicating the system is effective in the treatment of vein reflux associated with varicose veins and varicosities. No specific statistical metrics or sample sizes were provided in the summary.

Technological Characteristics

Nd:YAG laser system; 1320 nm wavelength; cabinet-housed power supply, cooling system, and microcontroller; fiber optic delivery; footswitch and pull-back device accessories. Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities in patients requiring surgical laser intervention.

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 CTEV (NS-160) Nd:YAG Laser Systems

Submission Summary (Full Text)

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## K 061618

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

SEP 2 5 2006

| 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 Model CTEV Nd:YAG Laser<br>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 CTEV (NS-160) Nd:YAG Laser<br>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 a cabinet, which houses the power supply,<br>cooling system, microcontroller and the laser, and the<br>fiber optic. Accessories include a footswitch and a fiber<br>optic pull-back device. |
| Intended use of CoolTouch<br>Nd: YAG Laser Systems: | The CoolTouch CTEV Nd:YAG Laser System is<br>indicated for the treatment of superficial incompetent<br>tributary veins associated with varicose veins and<br>varicosities. |
| SEP 25 2 | |

. . . . .

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| 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 vein reflux associated with varicose veins<br>and varicosities. |
| Conclusion: | The CoolTouch CTEV Nd:YAG Laser System is<br>indicated for the treatment of superficial incompetent<br>tributary veins associated with varicose veins and<br>varicosities. |
| Additional Information: | None requested at this time |

020

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. 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

## SEP 2 5 2006

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

Re: K061618

Trade/Device Name: CoolTouch CTEV 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: Class II Product Code: GEX Dated: August 16, 2006 Received: August 17, 2006

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 for associated or to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered prices 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 r ou may, ateres 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 or any I 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) I ma lotter witification. The FDA finding of substantial equivalence of your device to a legally promated 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 If you attire 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchner

Mark N. Melkerson 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

K061618 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch CTEV Nd: YAG Laser System

Indications for Use:

The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.

Prescription Use
(per 21 CFR 801.109)

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Over-the-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare Bnchum

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

510(k) Number K0611618

0004