PRO-PHACO HANDPIECE

PRO-PHACO HANDPIECE is an FDA 510(k)-cleared medical device (K933503) manufactured by M. Imonti and Associates 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 January 5, 1994. Regulation: 8.