S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-

S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- is an FDA 510(k)-cleared medical device (K001962) manufactured by Bescon Co., Ltd.. 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 8, 2001. Regulation: 8.