CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM

{0}------------------------------------------------ APR 2 9 1998 : 发 : K974674 : ## 510(k) Summary | Submitter | Cynosure, Inc. 10 Elizabeth Drive Chelmsford, MA 01824 | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Contact | George Cho Senior Vice President | | Date Summary Prepared | December 12, 1997 | | Device Trade Name | PhotoLight System | | Common Name | High intensity flashlamp system | | Classification Name | Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 | | Equivalent Device | The PhotoDerm VL by ESC Medical Systems | | Device Description | The PhotoLight pulsed light system is a medical device utilizing optical energy for photocoagulation of vascular lesions | | Intended Use | For the treatment of benign cutaneous vascular lesions | | Comparison | The PhotoLight is substantially equivalent to the PhotoDerm VL in terms of treatment parameters used and also the intended uses | | Nonclinical Performance Data | None | | Clinical Performance Data | None | | Conclusion | The PhotoLight System is another safe and effective way to treat vascular lesions | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 9 1998 Mr. George Cho ·Senior Vice President Cynosure, Incorporated 10 Elizabeth Drive 01824 Chelmsford, Massachusetts Re: K974674 Cynosure PhotoLight Flashlamp Trade Name: Regulatory Class: II Product Code: GEZ and KNS Dated: April 3, 1998 ________________________________________________________________________________________________________________________________________________________ Received: April 6, 1998 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 aqainst 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 requirement, as set ... . forth in the Quality System Regulation (QS) 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. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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. {2}------------------------------------------------ Page 2 - Mr. Cho 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, 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 {3}------------------------------------------------ 510(k) Number (if known): __K97 4674 Device Name: Cynosure PhotoLight System Indications for Ue: The PhotoLight System is indicated for the treatment of benign cutaneous vascular lesions. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) (Division Sign-Off Division of General Ra 510(k) Numb