PALOMAR LUX1540 HANDPIECE

K060301 · Palomar Medical Technologies, Inc. · GEX · Mar 23, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060301
• Device Name: PALOMAR LUX1540 HANDPIECE
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 23, 2006
• 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.

Device Story

The Palomar Lux1540 Handpiece is a laser surgical instrument designed for dermatological procedures. It delivers 1540 nm wavelength light to perform fractional photothermolysis, creating a lattice of microscopic islets of damage in superficial skin layers. The system comprises a power source, chiller, footswitch, and the handpiece connected via an umbilical. The handpiece tip is water-cooled for active skin cooling during contact. Operated by a clinician, the device is controlled via a user interface panel on the power unit. By inducing controlled thermal coagulation, the device facilitates dermatological treatments.

Clinical Evidence

Bench testing only. Performance data provided demonstrated the device's capability to perform fractional photothermolysis and create a lattice of microscopic islets of damage in superficial skin layers.

Technological Characteristics

Laser surgical instrument; 1540 nm wavelength; water-cooled handpiece tip for active skin cooling; system includes power source, chiller, footswitch, and handpiece. Operates via fractional photothermolysis.

Indications for Use

Indicated for dermatological procedures requiring the coagulation of soft tissue.

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

• Reliant Fraxel (K031795)

Submission Summary (Full Text)

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## Attachment 4

510(K) Summary of Safety and Effectiveness

K060301

This 510(K) Summary of Safety and Effectiveness for the Palomar Lux1540 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 2, 2006 |
| Device Trade Name: | Palomar Lux1540 Handpiece |
| Common Name: | Lux1540 |
| Classification Name: | Laser surgical instrument for use in General and<br>Plastic Surgery and Dermatology (21 CFR<br>878.4810) |
| Product Code: | GEX |
| Legally-Marketed Predicate Device: | Reliant Fraxel |

K031795

System Description:

The Palomar Lux1540 Handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to offer active skin System parameters and other system cooling. features are controlled from the user interface panel on top of the power unit.

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Intended Use of the Device: Dermatological requiring the Performance Data: Performance data was provided showing the Lux1540 is capable of performing fractional photothermolysis, i.e., creation of a pattern (lattice) of microscopic islets of damage at superficial skin layers. Conclusion: Based on the foregoing, the Palomar Lux1540 Handpiece is substantially equivalent to the legallymarketed claimed predicate device, namely the Reliant Laser System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

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

Re: K060301

Trade/Device Name: Palomar Lux1540 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: February 2, 2006 Received: February 6, 2006

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 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

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## Page 2 - Ms. Marcy Moore

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 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/dsma/dsmamain.html

Sincerely yours,

Helmut Lemke

Mark N. Melkerson 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

KOGO301 510(k) Number (if known):

Palomar Lux1540 Handpiece Device Name:

Indications for Use:

Dermatological procedures requiring the coagulation of soft tissue.

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)

Concurrence of CD (Division Sign-Off)

Division of General, Restorativ

and Neurological Devices

**510(k) Number** K060361