Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) is an FDA 510(k)-cleared medical device (K240169) manufactured by Bausch and Lomb, Incorporated. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 2024. Regulation: 8.