STELLARIS PC VISION ENHANCEMENT SYSTEM

STELLARIS PC VISION ENHANCEMENT SYSTEM is an FDA 510(k)-cleared medical device (K101325) manufactured by Bausch & Lomb, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 2010. Regulation: 8.