VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS is an FDA 510(k)-cleared medical device (K945172) manufactured by Visitec Co.. 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 16, 1995. Regulation: 8.