LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE is an FDA 510(k)-cleared medical device (K914484) manufactured by Hgm Medical Laser Systems, 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 January 5, 1992. Regulation: 8.