
Hydrogel Vision Corporation
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59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K040303) 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 February 1, 2005. Regulation: 8.