PALOMAR ASPIRE LASER PLATFORM

K083165 · Palomar Medical Products, Inc. · GEX · Feb 13, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083165
• Device Name: PALOMAR ASPIRE LASER PLATFORM
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Palomar Aspire™ Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.

Device Story

Transportable laser system; includes cart, power supply, software, user interface, footswitch, cooling system, and handpiece. Operates as laser surgical instrument for soft tissue coagulation and laser-assisted lipolysis. Used in clinical settings by physicians. Device delivers laser energy to target tissue; cooling system manages thermal effects. Output allows physician to perform surgical procedures; facilitates tissue coagulation and lipolysis. Benefits include precise tissue management during surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of technological characteristics.

Technological Characteristics

Transportable laser system; includes cart, power supply, software, user interface, footswitch, cooling system, and handpiece. Operates as a laser surgical instrument. Specific materials and ASTM standards not disclosed.

Indications for Use

Indicated for coagulation of soft tissue (skin, cutaneous, and subcutaneous tissue) and laser-assisted lipolysis in patients requiring surgical 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

• Palomar Aspire™ Laser Platform (K081416)
• Palomar Aspire™ Laser Platform (K080567)
• Sciton, Inc. Profile Multi-Platform System (K070388)
• Cynosure, Inc. Cynosure SmartLipo Multiwavelength Laser (K080121)
• Biolitec, Inc. Ceralas D 980 nm Diode Laser System (K081015)

Submission Summary (Full Text)

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## FEB 1 3 2009

#### 510(k) Summary

# KO83165

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

Applicant:

Contact:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Product Code:

Predicate Devices:

System Description:

Palomar Medical Technologies, Inc. 82 Cambridge St. Burlington, MA 01803

Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs [phone]

December 2, 2008

The Palomar Aspire™ Laser Platform

Medical laser system

Laser surgical instrument for use in General and Plastic Surgery and Dermatology (21 CFR 878.4810)

79 GEX

The Palomar Aspire™ Laser Platform Palomar Medical Technologies, Inc. K081416, K080567

Sciton, Inc. Profile Multi-Platform System K070388

Cynosure, Inc. Cynosure SmartLipo Multiwavelength Laser K080121

Biolitec, Inc. Ceralas D 980 nm Diode Laser System K081015

The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.

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Intended Use:

Performance:

Substantial Equivalence:

The Palomar Aspire™ Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.

The review of the technical characteristics, indications for use, risk analysis information, and verification and validation information provided demonstrate that the modified Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices.

The Palomar Aspire™ Laser Platform is as safe and effective as its predicate devices. The information provided in this application demonstrates the Palomar Aspire™ Laser Platform shares the same indications for use, similar technological characteristics and principals of operation. Therefore, the Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 1 3 2009

Re: K083165

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: October 24, 2008 Received: November 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, 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 (OS) 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 - Ms. Sharon Timberlake, RAC, CCRA

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 M. Mulhausen

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

Enolosure

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## Indications for Use

510(k) Number (if known): _ K O8 3 | Vo S

Device Name: Palomar Aspire™ Laser Platform

Indications for Use:

The Palomar Aspire™ Laser l'iatform is imen vel for coagalation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue.

The device is further indicated for laser assisted lipolysis.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 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)

Clank Miller

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

**510(k) Number** K083165

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CONFIDENTIAL