DROLITE(TM) LIGHT SOURCE

DROLITE(TM) LIGHT SOURCE is an FDA 510(k)-cleared medical device (K913273) manufactured by Vision Medical, 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 December 3, 1991. Regulation: 8.