BOSTON KERATOPROSTHESIS OR BOSTON KPRO

BOSTON KERATOPROSTHESIS OR BOSTON KPRO is an FDA 510(k)-cleared medical device (K121203) manufactured by Massachusetts Eye & Ear Infirmary. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 2013. Regulation: 8.