OCUSYSTEM ART ADVANTAGE, MODEL 995

OCUSYSTEM ART ADVANTAGE, MODEL 995 is an FDA 510(k)-cleared medical device (K991852) manufactured by Surgical Design Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 1999. Regulation: 8.