DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE is an FDA 510(k)-cleared medical device (K912384) manufactured by Nidek, 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 December 23, 1991. Regulation: 8.