MONITOR CO2 LASER SURGICAL SYSTEM

MONITOR CO2 LASER SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K840145) manufactured by Cooper Lasersonics, 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 April 24, 1984. Regulation: 8.