
Directed Energy, Inc.
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10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH is an FDA 510(k)-cleared medical device (K871031) 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 May 14, 1987. Regulation: 8.