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Accu-Pulse 1000 CO2 Surgical Laser System

by Argus Photonics Group

510(k) K983543

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983543 Date16 Dec 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Accu-Pulse 1000 CO2 Surgical Laser System is a DC-excited gas-slab pulsed CO2 surgical laser that produces 1-15 watts average power and operates at 9.6 or 10.6 microns wavelength. It utilizes a microprocessor-based control system with self-diagnosis capabilities.

The device is supplied as a surgical laser system for use in general and plastic surgery settings. It has received FDA 510(k) clearance (K983543) and is classified as a Class II medical device under product code GEX.

Other devices from Argus Photonics Group

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Accu-Pulse 1000 CO2 Surgical Laser System used for?

    The Accu-Pulse 1000 CO2 Surgical Laser System is used in general and plastic surgery settings as a surgical laser system for cutting, vaporizing, or coagulating tissue during procedures, based on its clearance for those indications.

  • What power output and wavelengths does the Accu-Pulse 1000 CO2 Surgical Laser System produce?

    The Accu-Pulse 1000 CO2 Surgical Laser System produces 1-15 watts average power and operates at either 9.6 or 10.6 microns wavelength, as specified in its technical description.

  • How is the Accu-Pulse 1000 CO2 Surgical Laser System controlled and monitored during operation?

    The Accu-Pulse 1000 CO2 Surgical Laser System utilizes a microprocessor-based control system with self-diagnosis capabilities to manage laser output and monitor system performance during use.

  • What regulatory clearance does the Accu-Pulse 1000 CO2 Surgical Laser System have?

    The Accu-Pulse 1000 CO2 Surgical Laser System has received FDA 510(k) clearance under K983543 and is classified as a Class II medical device under product code GEX.