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North American Clinical Lasers, Ltd.
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AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM is an FDA 510(k)-cleared medical device (K062248) manufactured by North American Clinical Lasers, Ltd.. 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 August 16, 2006. Regulation: 8.