PHACO FRAGMENTOR GT-1

PHACO FRAGMENTOR GT-1 is an FDA 510(k)-cleared medical device (K834453) manufactured by Fibra Sonics, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 1984. Regulation: 8.