MODIFICATION TO PALOMAR LUXIR HANDPIECE

K070298 · Palomar Medical Technologies, Inc. · GEX · Jul 3, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070298
• Device Name: MODIFICATION TO PALOMAR LUXIR HANDPIECE
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LuxIR is intended for photocoagulation of soft tissue in dermatologic applications. It also provides topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

LuxIR Handpiece is an accessory to the StarLux Pulsed Laser and Light System; emits infrared energy for photocoagulation and topical heating. System includes cart, console, chiller, footswitch, and handpiece. Operated by clinicians in dermatologic settings. Device elevates tissue temperature to provide therapeutic relief for musculoskeletal conditions and increase local circulation. Output is controlled infrared energy applied to the skin surface. Benefits include pain relief, muscle relaxation, and soft tissue coagulation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Infrared wavelength energy emitter; accessory to StarLux Pulsed Laser and Light System; includes chiller and footswitch components.

Indications for Use

Indicated for patients requiring photocoagulation of soft tissue in dermatologic applications or topical heating for temporary relief of minor muscle/joint pain, stiffness, arthritis-associated pain, muscle spasms, sprains, strains, and minor muscular back pain; also indicated for temporary increase in local circulation and muscle relaxation.

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

• StarLux LuxIR Handpiece (K060069 & K050370)

Submission Summary (Full Text)

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# 510(k) Summary LuxIR Handpiece

K070298

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

#### 1. SUBMITTER'S INFORMATION

| NAME: | Palomar Medical Technologies, Inc. | JUL - 3 2007 |
|----------|---------------------------------------------------------------------------------------------|--------------|
| ADDRESS: | 82 Cambridge Street<br>Burlington, MA 01803<br>Phone: [phone]<br>Fax: [phone] | |
| CONTACT: | Sharon Timberlake, RAC, CCRA<br>Director of Regulatory Affairs | |

DATE PREPARED: June 11, 2007

### DEVICE INFORMATION 2.

| TRADE/PROPRIETARY NAME: | Palomar LuxIR Handpiece |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Infrared Handpiece |
| CLASSIFICATION NAME: | Laser surgical instrument<br>21 CFR §878.4810<br>Infrared therapeutic heating lamp<br>21 CFR §878.4810 |

GEX, ILY

### 3. PREDICATE DEVICES

Product Code:

StarLux LuxIR Handpiece Palomar Medical Technologies, Inc. (K060069 & K050370)

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#### 4. INTENDED USE

The LuxIR is intended for photocoagulation of soft tissue in dermatologic applications. It also provides topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

#### 5. DEVICE DESCRIPTION

The LuxIR Handpiece is an accessory to the StarLux™ Pulsed Laser and Light System. The complete StarLux Pulsed Light System consists of a cart, system console, chiller, a footswitch, and a handpiece. The Palomar LuxIR Handpiece emits energy in the infrared wavelength.

#### 6. PERFORMANCE DATA

The review of the performance data provided in this notification demonstrates that the modified LuxIR Handpiece is substantially equivalent to its predicate device.

#### 7. SUBSTANTIAL EQUIVALENCE

The modified LuxIR Handpiece was found to be substantially equivalent to its predicate device because it shares identical indications for use, substantially similar technical characteristics, and operation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2007

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

Re: K070298 Trade/Device Name: Palomar LuxIR Handpiece Regulation Number: 21 CFR 878.4810400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 11, 2007 Received: June 12, 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 - 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 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

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): K070298

Device Name: Palomar LuxIR Handpiece

Indications for Use:

The LuxIR Handpiece is intended for:

- Photocoagulation of soft tissue in dermatologic applications. .
- . Provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

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

(Division Sign-Off)
OR Division of General, Restorative,
and Neurological Devices
Over-The-Counter Use
510(k) Number (Optional Format 1-2-96)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

PALOMAR MEDICAL TECHNOLOGIES, INC. LUXIR HANDPIECE

CONFIDENTIAL