FENCER 308 EXCIMER LASER SYSTEM

FENCER 308 EXCIMER LASER SYSTEM is an FDA 510(k)-cleared medical device (K080975) manufactured by Kera Harvest/Laser Max Medical Technologies Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2008. Regulation: 8.