EXPRESS MINI GLAUCOMA SHUNT

EXPRESS MINI GLAUCOMA SHUNT is an FDA 510(k)-cleared medical device (K030350) manufactured by Optonol, Ltd.. 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 12, 2003. Regulation: 8.