TRU-PULSE CO2 SURGICAL LASER

TRU-PULSE CO2 SURGICAL LASER is an FDA 510(k)-cleared medical device (K970804) 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 June 2, 1997. Regulation: 8.