OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)

OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) is an FDA 510(k)-cleared medical device (K952260) manufactured by Stellar Contact Lens, 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 January 2, 1996. Regulation: 8.