LASER FLARE CELL METER FC-1000

LASER FLARE CELL METER FC-1000 is an FDA 510(k)-cleared medical device (K880920) manufactured by Kowa 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 September 26, 1988. Regulation: 8.