OPTIMUM WETTING AND REWETTING DROP

OPTIMUM WETTING AND REWETTING DROP is an FDA 510(k)-cleared medical device (K001428) manufactured by Lobob Laboratories, 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 25, 2000. Regulation: 8.