
Aspen Laser Systems, LLC
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Aspen Laser Systems Therapy Laser System is an FDA 510(k)-cleared medical device (K150138) manufactured by Aspen Laser Systems, LLC. 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 May 7, 2015. Regulation: 8.