MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) is an FDA 510(k)-cleared medical device (K862150) manufactured by Directed Energy, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1986. Regulation: 8.