MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60

MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 is an FDA 510(k)-cleared medical device (K013864) manufactured by Nidek, 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 February 7, 2002. Regulation: 8.