
Laserscope
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AURA ISURGICAL LASER SYSTEM & ACCESSORIES is an FDA 510(k)-cleared medical device (K024206) manufactured by Laserscope. 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 November 16, 2003. Regulation: 8.