STELLARIS PC VISION ENHANCEMENT SYSTEM

STELLARIS PC VISION ENHANCEMENT SYSTEM is an FDA 510(k)-cleared medical device (K133486) manufactured by Bausch & Lomb. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2014. Regulation: 8.