PALOMAR ASPIRE LASER PLATFORM

K081416 · Palomar Medical Products, Inc. · GEX · May 29, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081416
• Device Name: PALOMAR ASPIRE LASER PLATFORM
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.

Device Story

The Palomar Aspire™ Laser Platform is a transportable medical laser system used for laser-assisted lipolysis. The system comprises a cart, power supply, software, user interface panel, footswitch, cooling system, and a handpiece. It is operated by a physician in a clinical setting. The device delivers laser energy to target tissue to facilitate lipolysis. The healthcare provider uses the user interface to control system parameters and monitors the procedure to perform the laser-assisted fat reduction. The device is intended to provide a surgical tool for fat removal, benefiting patients by facilitating the lipolysis process.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by technical characteristics, risk analysis, and verification and validation information.

Technological Characteristics

Transportable laser system including cart, power supply, cooling system, and handpiece. Operates as a laser surgical instrument (21 CFR 878.4810). Includes software and user interface panel. Connectivity and specific material standards are not detailed.

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

• The Palomar Aspire™ Laser Platform (K080567)

Submission Summary (Full Text)

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K081416

## 510(K) Summary

MAY 2 9 2008

This 510(k) Summary is being submitted in accordance with 21 CFR 807.92

| Applicant: | Palomar Medical Technologies, Inc.<br>82 Cambridge St.<br>Burlington, MA 01803 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Timberlake, MSHS, RAC, CCRA<br>Director of Regulatory Affairs<br>[phone] |
| Preparation Date: | May 19, 2008 |
| Device Trade Name: | The Palomar Aspire™ Laser Platform |
| Common Name: | Medical laser system |
| Classification Name: | Laser surgical instrument for use in General and Plastic Surgery<br>and Dermatology (21 CFR 878.4810) |
| Product Code: | 79 GEX |
| Predicate Device: | The Palomar Aspire™ Laser Platform<br>Palomar Medical Technologies, Inc.<br>K080567 |
| System Description: | The Palomar Aspire™ Laser Platform is a small transportable<br>system which includes a cart, power supply, software, user<br>interface panel, footswitch, cooling system and handpiece. |
| Intended Use: | The Palomar Aspire™ Laser Platform is indicated for laser<br>assisted lipolysis. |
| Performance: | The review of the technical characteristics, indications for<br>use, risk analysis information, and verification and validation<br>information provided demonstrate that the modified Palomar<br>Aspire™ Laser Platform is substantially equivalent to its<br>predicate device. |
| Substantial Equivalence: | The Palomar Aspire™ Laser Platform is as safe and effective<br>as its predicate devices. The information provided in this<br>application demonstrates the Palomar Aspire™ Laser<br>Platform shares the same indications for use, similar<br>technological characteristics and principals of operation.<br>Therefore, the Palomar Aspire™ Laser Platform substantially<br>equivalent to its predicate devices. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 9 2008

Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803

Re: K081416

Trade/Device Name: Palomar Aspire™ Laser Platform 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 19, 2008 Received: May 20, 2008

Dear Ms. Timberlake:

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. Iisting 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 - Sharon Timberlake, MSHS, RAC, CCRA

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. Milliman

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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## Indications for Use

510(k) Number (if known): _ KO8 14160

Device Name: Palomar Aspire™ Laser Platform

Indications for Use:

The Palomar Aspire™ Laser Platform 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel Rp. Opl - fr min

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

**510(k) Number** K081416

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