LUXVISION SLIT LAMP

LUXVISION SLIT LAMP is an FDA 510(k)-cleared medical device (K063416) 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 December 6, 2006. Regulation: 8.