
Thermolase Corp.
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SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY is an FDA 510(k)-cleared medical device (K993209) manufactured by Thermolase Corp.. 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 22, 1999. Regulation: 8.