CATAREX/ULTRASONICS KIT

CATAREX/ULTRASONICS KIT is an FDA 510(k)-cleared medical device (K840181) manufactured by Calliope Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 1984. Regulation: 8.