BIOFINITY (COMFILCON A) SOFT CONTACT LENS

BIOFINITY (COMFILCON A) SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K052560) manufactured by CooperVision, 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 December 5, 2005. Regulation: 8.