Mini-Halo(Hand-Held) CO2 Laser System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853319 ↗

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. →