AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 is an FDA 510(k)-cleared medical device (K925254) manufactured by Allergan Medical Optics. 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 6, 1993. Regulation: 8.