PEAK PULSAR II GENERATOR MODEL PS100-102

PEAK PULSAR II GENERATOR MODEL PS100-102 is an FDA 510(k)-cleared medical device (K102029) manufactured by Peak Surgical, 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 December 15, 2010. Regulation: 8.