PRIZM KERATOME BLADE, MODEL MK8512M2

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. Public Health Service MAR 2 6 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Surgin, Inc. c/o Mr. Don W. Haar QA/ Regulatory Manager 14762 Bentley Circle Tustin, CA 92680 Re: K033236 Trade/Device Name: Prizm Keratome Blade VII Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: February 9, 2004 Received: February 9, 2004 Dear Mr. Haar: 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 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. {1}------------------------------------------------ Page 2 - Mr. Don W. Haar 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) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours. A. heyl Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Surgin, Inc 14762 Bentley Circle Tustin. CA 92680 Tcl: 714 832 6300 ## INDICATIONS FOR USE STATEMENT 510(k) Number แหล่งข้อ Ko33236 Device Name: Pluzen KEIKTORE BLADE VIL Indications For Use: The Prizm Keratome Blade VII is to be used as a replacement blade for the blade in the pon-disposable M. H. Mac blade for the blade in the non-disposable Moria M2 keratome for lanellar resection of the corner for lamellar resection of the non-disportion (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrance of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-----------------------------------------------------|---------| | Division of Ophthalmic Ear, Nose and Throat Devises | | | 510(k) Number | K033236 | | Prescription Use | <div> <span style="text-decoration: underline;">✓</span> </div> | |----------------------|-----------------------------------------------------------------| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | | |----------------------|--| |----------------------|--| (Optional Format 1-2-96)