COOLTOUCH MODELS LC215 AND COOLLIPO

K080163 · New Star Lasers, Inc. · GEX · Apr 10, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080163
• Device Name: COOLTOUCH MODELS LC215 AND COOLLIPO
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 10, 2008
• 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 Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.

Device Story

CoolTouch LC215/CoolLipo is an Nd:YAG surgical laser system emitting at 1320 nm. Device consists of a cabinet housing power supply, cooling system, microcontroller, laser source, foot switch, and fiber optic delivery system with microcannula. Operated by physicians in clinical settings for laser-assisted lipolysis. Laser energy is delivered via fiber optic to target tissue; thermal effect facilitates lipolysis. System provides surgical laser capabilities for general, plastic surgery, and dermatology applications.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for laser-assisted lipolysis in patients requiring surgical fat reduction.

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 NS160 CoolLipo Nd: YAG laser system (K072751)
• CoolTouch LC215 Nd:YAG laser system (K072424)

Submission Summary (Full Text)

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Image /page/0/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with outstretched wings, symbolizing protection and care. The words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The word "DEPARTMENT" is written below the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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New Star Lasers, Inc. % Ms. Natalie R. Vollrath Quality Assurance Manager 9085 Foothills Boulevard Roseville, California 95747

APR 1 0 2008

Re: K080163

Trade/Device Name: CoolTouch LC215/CoolLipo 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: January 22, 2008 Received: January 23, 2008

Dear Ms. Vollrath:

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 R. 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.

Mark N. Millman

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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K080163

510(k) Number

이다. 주

| Device Name | CoolTouch LC215/CoolLipo Nd:YAG Laser System |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | In addition to previously cleared indications for use, the<br>CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser<br>is indicated for laser-assisted lipolysis. |

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

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)

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## Appendix 2 510(k) Summary

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## Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93)

This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch LC21/CoolLipoo This JTQ(K) Surgical Laser systems in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.

| Submitter: | New Star Lasers, Inc. d.b.a. CoolTouch, Inc. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Natalie Vollrath<br>Quality Assurance Manager |
| Telephone/Fax/Email: | [phone] - Phone<br>[phone] - Fax<br>[e-mail] - Email |
| Date prepared: | January 22, 2008 |
| Device Trade Name: | CoolTouch LC215/CoolLipo Nd:YAG Surgical<br>Laser |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR §878.4810 |
| Legally Marketed Predicate<br>Devices: | CoolTouch NS160 CoolLipo Nd: YAG laser<br>system (K072751)<br>CoolTouch LC215 Nd:YAG laser system<br>(K072424) |
| Device Description: | The CoolTouch LC215/CoolLipo Surgical Laser<br>System is an Nd:YAG laser producing laser<br>emission at 1320 nm. The laser consists of a<br>cabinet which houses the power supply, the<br>cooling system, microcontroller, laser, foot switch,<br>and the fiber optic for delivery of the laser energy<br>with microcannula setup. |

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| Intended Use: | In addition to previously cleared indications, the<br>Cooltouch LC215/CoolLipo is indicated for laser-<br>assisted lipolysis. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The Cooltouch LC215/CoolLipo has the same<br>principle of operation, the same wavelength and<br>essentially the same pulse energy rate as the<br>predicate devices. |
| Nonclinical Perfomance Data | None |
| Clinical Performance Data: | None |
| Conclusion: | The CoolTouch LC215/CoolLipo Nd:YAG<br>Surgical Laser System is substantially equivalent<br>to the predicate devices and is indicated for laser-<br>assisted lipolysis. |
| Additional Information: | None requested at this time. |