CYNOSURE PHOTOGENICA SV

{0}------------------------------------------------ NOV 2 0 2002 . -- ## 510(k) Summary : : : : : | | 510(k) Summary | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Submitter: | Cynosure, Inc. 10 Elizabeth Drive Chelmsford, MA 01824 | K021444 | | Contact: | George Cho | | | Date Summary Prepared: | November 20, 2002 | | | Device Trade Name: | PhotoGenica sV | | | Common Name: | Medical Laser System | | | Classification Name: | Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 | | | Equivalent Device: | PhotoGenica V | | | Device Description: | The PhotoGenica sV is a pulse-dye laser, having the organic dye as the lasting medium. It is pulsed dye laser with a wavelength of 585nm. | | | | Laser activation is by footswitch. Overall weight of the laser is 285lbs. and the size is 44"x19"x24" (HxWxD). | | | | Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase. | | | Intended Use: | The PhotoGenica sV is indicated for treatment of recurrent respiratory papillomatosis of the glottis. | | | Comparison: | The PhotoGenica sV laser has an equivalent indication for uses, the same principle of operation, the same wavelength and pulse energy range as the predicate devices. | | | Conclusion: | The PhotoGenica sV laser is another safe and effective device for soft tissue application. | | | Additional Information: | None. | | {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms. Public Health Service NOV 2 0 2002 Food and Drug Administratio 00 Corporate Boulevard Rockville MD 20850 Cynosure, Inc. George Cho Senior Vice President 10 Elizabeth Drive-Chelmsford, Massachusetts 01824 Re: K021444 Trade/Device Name: Cynosure PhotoGenica sV Laser Regulation Number: 878.4810 Regulation Name: Powered surgical laser instrument Regulatory Class: Class II Product Code: GEX Dated: August 21, 2002 Received: August 22, 2002 Dear Mr. Cho: 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 forth in the {2}------------------------------------------------ ## Page 2 - Mr. George Cho 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. 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" (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 Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): K021444 Device Name: Cynosure PhotoGenica sV Laser Indications For Use: The PhotoGenica sV laser is indicated for the treatment of recurrent respiratory papillomatosis of the glottis. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number KC2/444 Prescription Use OR Over-The-Counter Use_ (Optional Formal 1-2-96)