CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES

CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K052680) manufactured by KARL STORZ Endoscopy-America, 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 January 22, 2006. Regulation: 8.