← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K972002 # CYNOSURE DERMATOLOGY LASER COOLING TIP (K972002) _Cynosure, Inc. · GEX · Aug 27, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K972002 ## Device Facts - **Applicant:** Cynosure, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Aug 27, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures. ## Device Story The Cynosure Dermatology Laser Cooling Tip is an accessory device used in conjunction with dermatology laser systems. It functions by cooling the skin surface during laser treatment procedures to provide thermal protection or patient comfort. The device is operated by a physician or trained clinician in a clinical setting. It acts as a passive or active cooling interface between the laser delivery system and the patient's skin. By maintaining a lower skin temperature, it helps mitigate thermal injury or discomfort associated with laser energy application. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics The device is a cooling tip accessory for dermatology lasers. It functions as a thermal interface. No specific materials, energy sources, or software components are described. ## 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. ## 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}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. George Cho Senior Vice President, Medical Technology Cynosure, Inc. 35 Wiggins Avenue Bedford, Massachusetts 01730-2314 AUG 27 1997 Re: K972002 Trade Name: CYNOSURE Dermatology Laser Cooling Tip Regulatory Class: II Product Code: GEX Dated: May 29, 1997 Received: May 30, 1997 Dear Mr. Cho: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fallure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1 of 1 510(k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications fer Use: --------------------------------------------------------------------------------------------------------------------------------------------------------- The Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![Signature](signature.png) (Division Sign-Off) Division of General Restorative Devices | 510(k) Number | K972002 | |---------------|---------| |---------------|---------| | Prescription Use
(Per 21 CFR 801.109) |
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| OR | Over-the-Counter Use | |------------------------------------------|--------------|----|----------------------| |------------------------------------------|--------------|----|----------------------| (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K972002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K972002) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com