NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 15 1996 Dr. Alan J. Touch NovaVision, Inc. 2700-200 Gateway Centre Blvd. Morrisville, NC 27560 Re: K960584 Trade Name: NOVA-NEW Reconditioning System for Professional In-Office Use with NOVAWET, PERCEPTION and VANGUARD Daily Wear (rosilfocon A) Rigid Gas Permeable Lenses Regulatory Class: II Product Code: 86 HQD Dated: May 12, 1996 Received: May 17, 1996 Dear Dr. Touch: 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 - Dr. Alan J. Touch 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} NOVAVISON INC. 919 460 4487 P.02 Page 1 of 1 510(k) Number (if known): K960584 Device Name: NOVANEW Re-hydrophilization System for Professional In-Office Use on NOVAWET, VANGUARD AND PERCEPTION Rigid Gas Permeable Lenses for Daily Wear (rosilfocon A). Indications For Use: The Nova-New Lens Re-hydrophilization System is indicated for use for the in-office only re-hydrophilization of the NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses for daily wear. The Nova-New Lens Re-hydrophilization System is indicated when the practitioner, at his discretion, determines that he wishes to modify the surface of the contact lens. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED). Concurrence of CDRH, Office of Device Evaluation (ODE) myo Smith Dunon of Ophthalmic Devices Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) B