GEMINI OPHTHALMIC SURGERY SYSTEM

GEMINI OPHTHALMIC SURGERY SYSTEM is an FDA 510(k)-cleared medical device (K911808) manufactured by Alcon Laboratories. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 1991. Regulation: 8.