SURGITRON MODEL FFPF-EMC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three intertwined strands, representing health, and a human profile facing right, symbolizing human services. The seal is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 8 1997 Mr. Frank Lin Director of Engineering Ellman International, Inc. 1135 Railroad Avenue Hewlett, New York 11557-2316 � Re: K972072 Trade Name: Surgitron Model: FFPF-EMC Regulatory Class: II Product Code: GEI Dated: May 30, 1997 Received: June 3, 1997 Dear Mr. Lin: 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 Good Manufaciuring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 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}------------------------------------------------ ## Page 2 - Mr. Frank Lin 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, focsellez -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 __ |__ of __ of _________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known) K972072 Device Namie SURGITRON MODEL FFPF - EMC Indication For Use is idendical to the Surgitron as a preammendment device such as: * Culling Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection. や - * Blended Curring and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmenc Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures - Ilemostasıs Control of Blocding, Epilation, Telangectasia - * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Vernicae, Hemostasis. - * Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry). ( F. F. S. DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NFFDFD) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of General Restorative Devices | K972072 | | 510(k) Number | | | Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: overline;">X</span> | |---------------------------------------|---------------------------------------------------| |---------------------------------------|---------------------------------------------------| OR Over-The-Counter Use ______(Optional Format 1-2-96)