100W CERALAS D 980 LASER SYSTEM, MODEL D100

100W CERALAS D 980 LASER SYSTEM, MODEL D100 is an FDA 510(k)-cleared medical device (K050824) manufactured by Biolitec, 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 9, 2005. Regulation: 8.