FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM is an FDA 510(k)-cleared medical device (K984143) 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 February 15, 1999. Regulation: 8.