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Clearlab Pte , Ltd.
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SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR is an FDA 510(k)-cleared medical device (K003833) manufactured by Clearlab Pte , Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2001. Regulation: 8.