WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT is an FDA 510(k)-cleared medical device (K134036) manufactured by Loktal Medical Electronics Ind. Com. Ltda- Epp. 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 October 7, 2015. Regulation: 8.