ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM

ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM is an FDA 510(k)-cleared medical device (K850533) manufactured by Atlantic Optical Systems, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 1985. Regulation: 8.