MEGATRON OPHTHALMIC SURGICAL SYSTEM

MEGATRON OPHTHALMIC SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K961658) manufactured by Intl. Ophthalmic Industries Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 1996. Regulation: 8.