DENTEK LD 15 LASERSYSTEM

DENTEK LD 15 LASERSYSTEM is an FDA 510(k)-cleared medical device (K974057) manufactured by Dentek Lasersystems Produktions Ges.M.B.H.. 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 April 20, 1998. Regulation: 8.