DISPOSABLE VITRECTOMY HANDPIECE

DISPOSABLE VITRECTOMY HANDPIECE is an FDA 510(k)-cleared medical device (K832235) manufactured by Innovative Surgical Products, 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 September 28, 1983. Regulation: 8.