IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650

IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 is an FDA 510(k)-cleared medical device (K093627) manufactured by Shanghai Apolo Medical Technologies Co., Ltd.. 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 January 17, 2011. Regulation: 8.