Models 4000/6000/8000/8900 Laser for Derma/Surgery

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K873790 ↗

FDA Product Code

GEX

Models / Variants

4000

6000

8000

8900 Laser For Derma

Surgery

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Model Ls 840, CO2 Laser

  Class II

  FDA 510(k) K864563 Active Cleared 9 Apr 1987

• Argon/Krypton Laser System 8500

  Class II

  FDA 510(k) K844209 Active Cleared 6 Feb 1985

• Model Hse-5M Microwave Surgery Equipment/Microtaze

  Class II

  FDA 510(k) K864413 Active Cleared 9 Dec 1986

• Lasersonics Laser Cystoscope Model Fcy-6-35

  Class II

  FDA 510(k) K860822 Active Cleared 17 Apr 1986

• 870 Surgical Sys Control Pulse Modification

  Class II

  FDA 510(k) K852252 Active Cleared 27 Jun 1985

• Model 4900 Nd:yag Laser for Gastro & Genitour Appl

  Class II

  FDA 510(k) K880171 Active Cleared 11 Apr 1988

See all devices from Cooper Lasersonics, Inc. →

• What is the MODELS 4000/6000/8000/8900 Laser for Derma/Surgery used for?

  This device is a powered laser surgical instrument intended for use in general and plastic surgery applications, specifically designed for derma/surgery procedures as indicated in its FDA 510(k) clearance.

• Is the MODELS 4000/6000/8000/8900 Laser for Derma/Surgery reusable or single-use?

  The device is supplied as a reusable laser system for surgical use in clinical settings, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures.

• What regulatory clearance does the MODELS 4000/6000/8000/8900 Laser for Derma/Surgery have?

  The device received FDA 510(k) clearance under K873790 on January 22, 1988, as substantially equivalent to a predicate device, which is the regulatory pathway it followed for market authorization in the United States.