IRAS GLARE TESTER

IRAS GLARE TESTER is an FDA 510(k)-cleared medical device (K873987) manufactured by Randwal Instrument Co., 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 November 23, 1987. Regulation: 8.