
Directed Energy, Inc.
Free shipping on orders over $99 · 30-day returns
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY is an FDA 510(k)-cleared medical device (K862423) 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 September 14, 1986. Regulation: 8.