TRU-PULSE LASER (MODIFIED)

TRU-PULSE LASER (MODIFIED) is an FDA 510(k)-cleared medical device (K963683) manufactured by Tissue Technologies, 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 11, 1997. Regulation: 8.