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Hydrogel Vision Corporation
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EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) is an FDA 510(k)-cleared medical device (K051430) manufactured by Hydrogel Vision Corporation. 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, 2005. Regulation: 8.