MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM is an FDA 510(k)-cleared medical device (K912904) manufactured by Mentor O & O, 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 June 10, 1992. Regulation: 8.