IRAS EDS INTERFEROMETRIC STIMULATOR

IRAS EDS INTERFEROMETRIC STIMULATOR is an FDA 510(k)-cleared medical device (K873990) 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 February 4, 1988. Regulation: 8.