OMS SLIMLINE PHACO HANDPIECE

OMS SLIMLINE PHACO HANDPIECE is an FDA 510(k)-cleared medical device (K950218) manufactured by Optical Micro 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 July 16, 1995. Regulation: 8.