
Curae'Lase, Inc.
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CL10009 IR LASER is an FDA 510(k)-cleared medical device (K130168) manufactured by Curae'Lase, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2014. Regulation: 8.