BIO-EYE II ORBITAL IMPLANT

BIO-EYE II ORBITAL IMPLANT is an FDA 510(k)-cleared medical device (K003338) manufactured by Integrated Orbital Implants, 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 February 6, 2001. Regulation: 8.