U.S. IOL PHACO HANDPIECE

U.S. IOL PHACO HANDPIECE is an FDA 510(k)-cleared medical device (K954239) manufactured by U.S. Iol, 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 7, 1995. Regulation: 8.