HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)

HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) is an FDA 510(k)-cleared medical device (K023530) manufactured by Westcon Contact Lens Co., 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 November 25, 2002. Regulation: 8.