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Curae'Lase, Inc.
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CURAE'LASE CL1000 IR LASER SYSTEM is an FDA 510(k)-cleared medical device (K053201) 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 December 8, 2005. Regulation: 8.