VISTAKON (SENOFILCON A) SOFT CONTACT LENS

VISTAKON (SENOFILCON A) SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K042275) manufactured by Vistakon. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2004. Regulation: 8.