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Ocular Sciences, Inc.
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HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K031477) manufactured by Ocular Sciences, 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 July 17, 2003. Regulation: 8.