ERBIUM FRACTIONAL HANDPIECE

K071768 · Palomar Medical Products, Inc. · GEX · Nov 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071768
• Device Name: ERBIUM FRACTIONAL HANDPIECE
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dermatological procedures requiring the coagulation of soft tissue; Skin resurfacing procedures.

Device Story

Erbium Fractional Handpiece is an accessory for laser systems used in dermatology; performs skin resurfacing and soft tissue coagulation. Device delivers fractional laser energy to skin; creates micro-thermal zones to stimulate tissue response. Operated by physicians in clinical settings. Output is controlled laser energy; allows precise treatment of skin conditions. Benefits include improved skin texture and appearance through controlled thermal injury.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Laser surgical instrument; fractional delivery mechanism; intended for use with laser systems. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation and skin resurfacing.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K071768 Trade/Device Name: Erbium Fractional Handpiece 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: September 27, 2007 Received: September 28, 2007

NOV - 5 2007

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 (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 - 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 Office 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 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. 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): K071768

Device Name: Erbium Fractional Handpiece

Indications for Use:

Dermatological procedures requiring the coagulation of soft tissue;

Skin resurfacing procedures.

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Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| Prescription Use | X (Per 21 CFR 801.109) |
|----------------------|------------------------|
| 510(k) Number | 1102176 |
| Over-The-Counter Use | |

(Optional Format 1-2-96)

PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): ERBIUM FRACTIONAL HANDPIECE CONFIDENTIAL Page 1