
American Laser Medical
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FLEX-LASE 600 SERIES ION LASER SYSTEM is an FDA 510(k)-cleared medical device (K963389) manufactured by American Laser Medical. 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 25, 1996. Regulation: 8.