XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000

XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 is an FDA 510(k)-cleared medical device (K011382) manufactured by Photo Medex, Inc.. 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 August 1, 2001. Regulation: 8.