Model 20-B CO2 Laser System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854399 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Carbon Dioxide Laser System Model 20-Cx W/Attach.

  Class II

  FDA 510(k) K883738 Active Cleared 15 Nov 1988

• Model 8-B with La-2B Attachment for Ob-Gyn Use

  Class II

  FDA 510(k) K861845 Active Cleared 11 Aug 1986

• Model 20-B CO2 Laser for General & Plastic Surgery

  Class II

  FDA 510(k) K862422 Active Cleared 2 Oct 1986

• Model 8-B with Os-1 Attachment (C02 Laser for ENT)

  Class II

  FDA 510(k) K862150 Active Cleared 4 Sep 1986

• Model 20-Ch W/ Ar-10A/U Optical Attachment

  Class II

  FDA 510(k) K894241 Active Cleared 18 Jun 1990

• Model 20-B W/Ob-10A/U Attach. for Ear, Nose/Throat

  Class II

  FDA 510(k) K872710 Active Cleared 24 Sep 1987

See all devices from Directed Energy, Inc. →

• What is the primary clinical application for the Model 20-B CO2 Laser System?

  This device is specifically intended for use in general and plastic surgery procedures. It utilizes carbon dioxide laser technology to perform precise tissue ablation and cutting during these surgical interventions.

• What is the regulatory status of this laser system?

  The Model 20-B CO2 Laser System has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices for the same intended use.

• Who is the manufacturer of the Model 20-B CO2 Laser System?

  The device is manufactured and supplied by Directed Energy, Inc., located in Los Angeles, California. They are the primary contact for this specific medical laser system under the K854399 submission.