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Innova Vision, Inc.
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I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 is an FDA 510(k)-cleared medical device (K033136) manufactured by Innova Vision, 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 March 4, 2004. Regulation: 8.