PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE

PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE is an FDA 510(k)-cleared medical device (K925631) manufactured by Chiron Intraoptics. 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 28, 1993. Regulation: 8.