← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K023967 # PALOMAR Q-YAG ND:YAG LASER SYSTEM (K023967) _Palomar Medical Technologies, Inc. · GEX · Jan 27, 2003 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K023967 ## Device Facts - **Applicant:** Palomar Medical Technologies, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jan 27, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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). ## Regulatory 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](/device/K971207.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 023967 1/2 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.
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
Plastic Surgery and in Dermatology
(see: 21 CFR 878-4810).
Product Code: GEX
Panel: 79 | | Legally-Marketed Predicate Device: | ThermoLase SoftLight
K971207 | | System Description: | The complete system consists of a power supply
unit, a cooling unit, a foot switch, and the hand
piece that connects the laser unit and cooling unit
using an umbilical cord. In standard use, the hand
piece is held against the treatment area and the light
pulse is delivered when the foot switch and hand
switch is depressed. Laser parameters and other
system features are controlled from a display panel | located on the front of the power supply unit. {1}------------------------------------------------ 023967 2/2 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K023967](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K023967) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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