CERALAS DIODE LASER SYSTEM (CERALAS D2)

CERALAS DIODE LASER SYSTEM (CERALAS D2) is an FDA 510(k)-cleared medical device (K964751) manufactured by Ceram Optec, 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 February 20, 1997. Regulation: 8.