SURECAUT DIAMOND LASER KNIFE

{0}------------------------------------------------ MED OPTICS Dlamond LaserKnife™ Premarket Notification 1510(k)] -- K983463 1c983463 DFC 1 1 1998 ## FDA Premarket Notification [510(k)] Summary Preparation Date: 24 November 1998 Contact: Gerald S. Palecki, Director, Quality and Regulatory Device Name: Proprietary: Diamond LaserKnife™ Common: Laser Scalpel Predicate Device: Sapphire Laser Scalpel, reference K863086 Device Description: The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized. ## Intended Use: The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use. Technological Characteristics Compared to Predicate Device: A crystal with sharpened edges is used as a scalpel to cut tissue during surgical procedures and also conducts laser energy to the tissue to cauterize and coagulate. Non-Clinical Tests: The Diamond LaserKnife 1 " performance characteristics have been evaluated through analysis of laser energy fields emitted from the tip when the laser is energized compared to similar devices cleared for marketing in the past. Conclusions Drawn from Tests and Analysis: The predicted energy levels at the point of application meet criteria derived from performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to the discrete values of fluence. 510_CvDLK5 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 1 1998 Mr. Gerald S. Palecki Director, Quality and Regulatory Clinicon Corporation 2752 Loker Avenue West Carlsbad, California 92008 Re: K983463 Trade Name: Diamond LaserKnife™ Regulatory Class: II Product Code: GEX Dated: September 30, 1998 Received: October 1, 1998 Dear Mr. Palecki: 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 requirement, 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. 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. {2}------------------------------------------------ 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}------------------------------------------------ Page 1 of 2 510(k) Number: K983463 Device Name: ____Diamond Laserknife™ Indications for Use: The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, and urological procedures. See Attachment 2 for a listing of medical specialties and typical contact laser procedures. 510_DLK_Ind2 (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurence of CDRH, Office of Device Evaulation (ODE) | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of General Restorative Devices | | | 510(k) Number | C983463 | Prescription Use (Optional Format 3-10-98) {4}------------------------------------------------ CLINICON CORPORATION Premarket Notification 1510(k)] -- K983463 Diamond LaserKnife ™ ## Attachment 2 Listing of medical specialties and typical contact laser procedures. - 1. Dentistry/Oral Surgery Incisional/excisional biopsies, removal of benign and cancerous lesions, frenectomy, gingivectomy, gingivoplasty, operculectomy, coagulation of graft donor sites, removal of vascular lesions, minor flap surgery, leukoplakia, and lymphangioma. ## 2. Dermatology Removal of warts, neruofibromas, hemangioma, epidermal nevi, eruptive vellus hair cysts, telangiectasia, basal cell carcinoma, and granuloma. - 3. General and Plastic Surgery Removal of skin tumors, hemorrhoidectory, lipomas, partial splenectomy, and rectal strictures. Blepharoplasty, breast reduction/reconstruction, and hair grafts. - 4. Neurosurgery: Incision/excision of tumors, lesions, and cysts, - 5. Ophthalmology Incision/excision of periorbital lesions. - 6. Oto-rhino-laryngology Excision of pulmonary lesions, vocal cord dysplasia and carcinoma. bronchoectorny, cordectomy, polyps, larynx leukoplakia, papillomas, lymphangioma, and myringotomy. - 7. Podiatry Excision of Morton's neruoma, porokeratotic lesions, and plantar warts. - 8. Urology Benign neoplasia and carcinoma of external genitalia, urethral condyloma, phimosis, and renal resection. **Prescription Use** **(Per 21 CFR 801.109)** Pcolleto (Division Sign-Off) I.S. Central Restorative Devices 16003463 ivision Sign-Off) ivision of General Restorative Devices 10(k) Number .