PALOMAR LUXIR HANDPIECE

K050370 · Palomar Medical Technologies, Inc. · ILY · Jun 15, 2005 · Physical Medicine

Device Facts

• Record ID: K050370
• Device Name: PALOMAR LUXIR HANDPIECE
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Palomar LuxIR Handpiece is intended to emit energy in the infrared spectrum to 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, the Palomar LuxIR Handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

The Palomar LuxIR Handpiece is an infrared heating device that delivers energy in the 800-1800 nm wavelength range. The system comprises a power source, chiller, footswitch, and the handpiece connected via an umbilical. During operation, the clinician holds the handpiece in firm contact with the patient's skin. The handpiece tip features active water-cooling to manage skin temperature. System parameters are managed via a user interface on the power unit. By elevating local tissue temperature, the device provides temporary relief of minor muscle and joint pain, stiffness, and spasms, while promoting local circulation and muscle relaxation. It is intended for use in a clinical setting by healthcare professionals.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Infrared heating lamp (21 CFR 890.5500). Wavelength: 800-1800 nm. Features active water-cooled tip for skin cooling. System includes power source, chiller, footswitch, and handpiece. Operated via user interface panel on power unit.

Indications for Use

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

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Cutera Optional Infrared Handpiece (K033768)

Submission Summary (Full Text)

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K050370 1 of 2

## Attachment 3

JUN 1 5 2005

510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the Palomar LuxIR handpiece is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Palomar Medical Technologies, Inc. | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Address: | 82 Cambridge St.<br>Burlington, MA 01803 | |
| Contact Person: | Marcy Moore | |
| Telephone: | 919-363-2432 | |
| Preparation Date: | February 10, 2005 | |
| Device Trade Name: | Palomar LuxIR Handpiece | |
| Common Name: | Infrared Handpiece | |
| Classification Name: | Infrared Heating Lamp<br>(21 CFR 890.5500). | |
| Legally-Marketed Predicate Device:K033768<br>Cutera Optional Infrared Handpiece | | |
| System Description: | The Palomar LuxIR Handpiece delivers infrared<br>light with a wavelength of 800-1800 nm. The<br>complete system consists of a power source, chiller,<br>a footswitch, and a handpiece connected to the<br>power unit with an umbilical. In standard use, the<br>handpiece is held in firm contact with the skin. The<br>handpiece tip is water-cooled to provide active skin<br>cooling. System parameters and other system<br>features are controlled from the user interface panel<br>on top of the power unit. | |

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## K050370

| Intended Use of the Device: | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Palomar LuxIR Handpiece is intended to emit<br>energy in the infrared spectrum to provide topical<br>heating for the purpose of elevating tissue<br>temperature for the temporary relief of minor<br>muscle and joint pain and stiffness, the temporary<br>relief of minor joint pain associated with arthritis,<br>the temporary increase in local circulation where<br>applied, and the relaxation of muscles. In addition,<br>the Palomar LuxIR Handpiece may also help<br>muscle spasms, minor sprains and strains, and<br>minor muscular back pain. |
| Performance Data: | The differences in the specifications of the Palomar<br>LuxIR Handpiece and the predicate device do not<br>result in different performance or raise new<br>questions of safety or efficacy. |
| Conclusion: | Based on the foregoing, the Palomar LuxIR<br>Handpiece is substantially equivalent to the legally-marketed claimed predicate device. |

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUN 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Palomar Medical Technologies Incorporated C/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511

Re: K050370

Trade/Device Name: Palomar LuxIR Handpiece Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 6, 2005 Received: May 9, 2005

Dear Ms. Moore:

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 10 wor would 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. Marcy Moore

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your were of your device of your device to a legally premarket nouffication. "The PDF Intering of basically 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 Patis and the pritised If you desire specific advice for your do need on our bland on the regulation entitled, and Conlict the Office of Comphalice as (21 t mart 807.97). You may obtain " Misbranding by relevence to premance nouthead.com the Act from the Division of Small
other general information on your responsibilities under the Act from the 2000 C20.00 other general information on your responsible and its toll-free number [phone] or and Manufacturers, International and Consumer 11/vww.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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): K050370

1 of 1

10(k) Number (if known): K0502

Device Name:

Palomar LuxIR Handpiece

Indications for Use:

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Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(21 CFR 801 Subpart C)

7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ivision Sign-C If) on Signeral, Restorative and Neurological Devices

510(k) Number K25370