Boston Keratoprosthesis, Type I Lucia

Boston Keratoprosthesis, Type I Lucia is an FDA 510(k)-cleared medical device (K182986) manufactured by Massachusetts Eye and Ear Infirmary D/B/A Boston. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2019. Regulation: 8.