PALOMAR Q-YAG ND:YAG LASER SYSTEM

K023967 · Palomar Medical Technologies, Inc. · GEX · Jan 27, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023967
• Device Name: PALOMAR Q-YAG ND:YAG LASER SYSTEM
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Palomar Q-YAG™ is indicated for laser skin resurfacing with or without adjuvant preparation.

Device Story

The Palomar Q-YAG Nd:YAG Laser System is a surgical laser device used for skin resurfacing. The system comprises a power supply unit, a cooling unit, a foot switch, and a handpiece connected via an umbilical cord. The operator, typically a clinician, controls laser parameters via a display panel on the power supply. During operation, the handpiece is placed against the treatment area, and light pulses are delivered upon activation of the foot and hand switches. The device utilizes laser energy to perform skin resurfacing, potentially benefiting patients by improving skin texture or appearance. It is intended for use in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Nd:YAG laser system operating at 1064 nm wavelength. System includes power supply, cooling unit, foot switch, and handpiece. Laser parameters are controlled via a front-panel display. Device is a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for laser skin resurfacing with or without adjuvant preparation at the 1064 nm wavelength.

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

• ThermoLase SoftLight (K971207)

Submission Summary (Full Text)

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JAN 2 7 2003

## Attachment 4

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the Q-YAGTM Nd:YAG Laser System 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: | 11/25/02 |
| Device Trade Name: | Palomar Q-YAGTM Nd:YAG Laser System |
| Common Name: | Q:Switched Nd:YAG |
| Classification Name: | Laser surgical instrument for use in General and<br>Plastic Surgery and in Dermatology<br>(see: 21 CFR 878-4810).<br>Product Code: GEX<br>Panel: 79 |
| Legally-Marketed Predicate Device: | ThermoLase SoftLight<br>K971207 |
| System Description: | The complete system consists of a power supply<br>unit, a cooling unit, a foot switch, and the hand<br>piece that connects the laser unit and cooling unit<br>using an umbilical cord. In standard use, the hand<br>piece is held against the treatment area and the light<br>pulse is delivered when the foot switch and hand<br>switch is depressed. Laser parameters and other<br>system features are controlled from a display panel |

located on the front of the power supply unit.

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Intended Use of the Device:

The Palomar Q-YAG™ is indicated for laser skin resurfacing with or without adjuvant preparation.

The differences in the specifications of the

laser and the predicate device do not result in

Performance Data:

Conclusion:

different performance or raise new questions of safety or efficacy. Based on the foregoing, the Palomar Q-YAGTM

Nd:YAG Laser System is substantially equivalent to the legally-marketed claimed predicate device, i.e., the Thermolase SoftLight.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in black, contrasting with the white background.

JAN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023967

Trade/Device Name: Palomar Q-YAGTM Nd:YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 27, 2002 Received: November 29, 2002

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

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Page 2 -- Ms. Marcy Moore

(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. 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). Other general information on your responsibilities under the Act may be obtained 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.

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

KO23967 510(K) Number:

Device Name: Palomar Q-Y AGTM Nd: Y AG Laser System

Indications for Use:

The Palomar Q-YAGTM Nd:YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR Over-the-Counter Use --(per 21 CFR 801.109)

Miriam C. Provost

Ivision Sign-Off) Division of General, Restorative and Neurological Vevices

Number K023967