NOVALENS/NOVAWET PERCEPTION AND VANGUARD

NOVALENS/NOVAWET PERCEPTION AND VANGUARD is an FDA 510(k)-cleared medical device (K942533) manufactured by Ocutec Corporation, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 4, 1994. Regulation: 8.