K-LASER, MODELS 3,4,4D,6D

K-LASER, MODELS 3,4,4D,6D is an FDA 510(k)-cleared medical device (K050070) manufactured by Eltech S.R.L. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 2005. Regulation: 8.