MEDICAL OPTICS PHACOEMULSIFICATION KIT

MEDICAL OPTICS PHACOEMULSIFICATION KIT is an FDA 510(k)-cleared medical device (K844150) manufactured by American 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 December 10, 1984. Regulation: 8.