MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)

MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) is an FDA 510(k)-cleared medical device (K080180) manufactured by Optical Imaging , 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 June 10, 2008. Regulation: 8.