GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72

GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 is an FDA 510(k)-cleared medical device (K080776) manufactured by Us Ophthalmic, LLC. 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 8, 2008. Regulation: 8.