BIOCERAMIC ORBITAL IMPLANT

BIOCERAMIC ORBITAL IMPLANT is an FDA 510(k)-cleared medical device (K992294) manufactured by Fci Ophthalmics, 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 April 18, 2000. Regulation: 8.