AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM is an FDA 510(k)-cleared medical device (K951462) 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 June 14, 1995. Regulation: 8.