LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)

LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) is an FDA 510(k)-cleared medical device (K113390) manufactured by Meridian AG. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2012. Regulation: 8.