
Optonol, Ltd.
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EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS is an FDA 510(k)-cleared medical device (K012852) 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 25, 2002. Regulation: 8.