
Metro Optics of Austin, Inc.
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SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR is an FDA 510(k)-cleared medical device (K031532) manufactured by Metro Optics of Austin, 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 31, 2003. Regulation: 8.