
Optisonic, Inc.
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OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES is an FDA 510(k)-cleared medical device (K000998) manufactured by Optisonic, 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 June 4, 2000. Regulation: 8.