COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY

K090410 · New Star Lasers, Inc. · GEX · Mar 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090410
• Device Name: COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

For use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS130 laser.

Device Story

Thermal sensing handpiece accessory; measures and displays treatment area temperature during NS130 laser procedures. Used by laser operators in clinical settings. Provides real-time temperature feedback to assist in monitoring treatment area conditions. Benefits patient by enabling temperature-controlled laser application.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Temperature detector/sensor accessory for laser handpiece. Provides visual readout of treatment area temperature. Designed for integration with NS130 laser system.

Indications for Use

Indicated for use as a temperature sensing and display device for the treatment area during procedures performed with the NS130 laser system.

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 Temperature Diagnostic Accessory

Submission Summary (Full Text)

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## Premarket Notification 510(k) Summary CoolTouch Thermal Sensing Handpiece Accessory

This 510(K) Summary of safety and effectiveness for the CoolTouch Thermal Sensing Handpiece Accessory is submitted in accordance with the requirements of 21CFR 807.92.

| Applicant: | New Star Lasers, Inc. dba CoolTouch, Inc. | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 | MAR 2 7 2009 |
| Contact Person: | Natalie R. Vollrath | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| Preparation Date: | February 17, 2009 | |
| Device Trade Name: | CoolTouch Thermal Sensing Handpiece Accessory | |
| Common Name: | Handpiece Accessory | |
| Classification Name: | Instrument, Surgical Powered, Laser 79-GEX | |
| Legally Marketed Predicate<br>Device: | New Star Temperature Diagnostic Accessory | |
| Description of the CoolTouch<br>Thermal Sensing Handpiece<br>Accessory: | The Thermal Sensing Handpiece Accessory is a temperature<br>detector which will provide the laser operator with a readout<br>of the temperature of the treatment area | |
| Intended use of the CoolTouch<br>Thermal Sensing Handpiece<br>Accessory: | For use as a sensing device to measure and display the<br>temperature of the treatment area during procedures with the<br>NS130 laser | |
| Performance Data: | None | |
| Conclusion: | Based on the evaluation of the risks and hazards and<br>including various testing of the modifications, the<br>CoolTouch Thermal Sensing Handpiece Accessory is<br>substantially equivalent to the predicate device, the New<br>Star Temperature Diagnostic Accessory | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

New Star Lasers, Inc. % Ms. Natalie Vollrath OA/RA Manager 9085 Foothills Boulevard Roseville, California 95747

MAR 2 7 2009

Re: K090410

Trade/Device Name: CoolTouch Thermal Sensing Handpiece Accessory 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: March 19, 2009

Dear Ms. Vollrath:

Received: March 23, 2009

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

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Page 2 - Ms. Natalie Vollrath

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

R.A. m.D. for

Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number

Device Name CoolTouch Thermal Sensing Handpiece Accessory Indications for The CoolTouch Thermal Sensing Handpiece Accessory is intended Usc for use as a sensing device to measure and display the temperature

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

of the treatment area during procedures with the NS-130 Laser.

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for mkm 3/27/2009

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

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510(k) Number Logo410

Confidential