Model 8A Previously Mini Halo CO2 Laser System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854387 ↗

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 Model 8A Previously Mini Halo CO2 Laser System used for?

  The Model 8A Previously Mini Halo CO2 Laser System is intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. It is designed for use in general surgery and dermatology procedures, as stated in the device description.

• Who manufactures the Model 8A Previously Mini Halo CO2 Laser System and when was it cleared?

  The Model 8A Previously Mini Halo CO2 Laser System is supplied by Directed Energy, Inc. and received FDA 510(k) clearance on February 7, 1986, based on the authorization and date provided in the device data.

• Is the Model 8A Previously Mini Halo CO2 Laser System designated for single-use or reusable applications?

  The device is not specified as single-use or reusable in the provided information. No details about reusability or disposability are included in the device data, so this characteristic cannot be determined from the given facts.

• What regulatory pathway and product code apply to the Model 8A Previously Mini Halo CO2 Laser System?

  The device was cleared via the FDA 510(k) pathway and is authorized under product code GEX, as indicated in the AUTHORIZATIONS and SPECIFICATIONS sections of the device data.