OPTIMED GLAUCOMA PRESSURE REGULATOR

OPTIMED GLAUCOMA PRESSURE REGULATOR is an FDA 510(k)-cleared medical device (K903462) manufactured by Optimed, 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 October 15, 1990. Regulation: 8.