OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE

OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE is an FDA 510(k)-cleared medical device (K062336) manufactured by Optimedica Corporation. 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 October 18, 2006. Regulation: 8.