STRATAPULSE TS AND STRATAPULSE

STRATAPULSE TS AND STRATAPULSE is an FDA 510(k)-cleared medical device (K090837) manufactured by Advanced Medical Photonics. 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 16, 2009. Regulation: 8.