EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 20 1997 Euclid Systems Corporation c/o Ms. Paula Tirrell Regulatory Assistant Schiff & Company® 1129 Bloomfield Avenue West Caldwell, NJ 07006 Re: K964702 Trade Name: Euclid Systems Corneal Topographer Model ET800 Regulatory Class: I Product Code: 86 MMQ Dated: March 25, 1997 Received: March 28, 1997 Dear Ms. Tirrell: 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 Manufacturing 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 - Ms. Paula Tirrell 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) 594-4613. 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 at (301) 443-6597. Sincerely yours,  A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} 510(k) Premarket Notification Euclid Systems Corporation - ET800 Corneal Topography System 510(k) Number (if known): K 964702 Device Name: EUCLID CORNEAL TOPOGRAPHY SYSTEM Indications for Use: Corneal Topographer: Indicated for use for measuring the shape and curvature of the anterior surface of the cornea of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the cornea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism. (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 ☐ (Per 21 CFR 801.109) (Optional Format 1-2-96) Drew M. M. (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K 964702 Prepared by Schiff & Company, West Caldwell, NJ Page 10 CK = 34