
Directed Energy, Inc.
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MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM is an FDA 510(k)-cleared medical device (K854387) manufactured by Directed Energy, Inc.. 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 February 6, 1986. Regulation: 8.