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Lobob Laboratories, Inc.
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MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND is an FDA 510(k)-cleared medical device (K014162) 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 January 14, 2002. Regulation: 8.