PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE is an FDA 510(k)-cleared medical device (K912902) manufactured by Site Microsurgical Systems, 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 December 16, 1991. Regulation: 8.