Model 20-B CO2 Laser System

K854399 is the FDA 510(k) clearance record for MODEL 20-B CO2 LASER SYSTEM, a class II device, cleared for Directed Energy, Inc. on 1986-02-07 under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 39 510(k) clearances for Directed Energy, Inc., from 1984-07-09 to 1991-03-21. As of 2026-09-10, FDA records show no recalls naming K854399.