UNITED SONICS PHACO MODULE, DF-35

UNITED SONICS PHACO MODULE, DF-35 is an FDA 510(k)-cleared medical device (K851210) manufactured by United 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 May 30, 1985. Regulation: 8.