AOI UNIVERSAL ULTRASONIC HANDPIECE

AOI UNIVERSAL ULTRASONIC HANDPIECE is an FDA 510(k)-cleared medical device (K950880) manufactured by American Optical Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 1995. Regulation: 8.