
Iop, Inc.
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KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT is an FDA 510(k)-cleared medical device (K090078) manufactured by Iop, 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 May 7, 2009. Regulation: 8.