SOLA COMMIDO LOUPE

SOLA COMMIDO LOUPE is an FDA 510(k)-cleared medical device (K760770) manufactured by Codman & Shurtleff, 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 14, 1976. Regulation: 8.