KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II

KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II is an FDA 510(k)-cleared medical device (K980398) manufactured by Optomedic Medical Technologies , Ltd.. 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 September 21, 1998. Regulation: 8.