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Spectra-Sp CO2 Laser System

by Max Engineering, Ltd.

510(k) K050254

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 NumberK050254 Date15 Apr 2005ClearedStatusActive

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  • Withdrawn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
FDA applicant
Max Engineering , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Spectra-Sp CO2 Laser System is a surgical CO2 laser console that utilizes a DC-excited sealed-off CO2 gas tube to produce a 10.6μm coherent infrared beam. It features an articulated arm delivery system with handpiece and focus lens, and includes a footswitch and goggles for operation.

The device is operated by clinicians in surgical settings and contains a cooling system, power supply, and control panel with emergency stop. The Spectra-Sp CO2 Laser System is authorized under FDA 510(k) clearance with product code GEX and K-number K050254.

Other devices from Max Engineering, Ltd.

Questions

AI-generated answers, 27 Sep 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 Spectra-Sp CO2 Laser System used for in surgical settings?

    The Spectra-Sp CO2 Laser System is a surgical console that produces a 10.6μm coherent infrared beam for use in various surgical procedures. It features an articulated arm delivery system with handpiece and focus lens, designed for precision in clinical environments.

  • What components are included with the Spectra-Sp CO2 Laser System?

    The system includes a DC-excited sealed-off CO2 gas tube, articulated arm delivery system with handpiece and focus lens, footswitch for operation, protective goggles, cooling system, power supply, and control panel with emergency stop functionality.

  • What is the regulatory status of the Spectra-Sp CO2 Laser System?

    The Spectra-Sp CO2 Laser System is authorized under FDA 510(k) clearance with product code GEX and K-number K050254. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway.

  • How is the Spectra-Sp CO2 Laser System operated and maintained?

    The device is operated by clinicians using the footswitch while wearing protective goggles. It contains a built-in cooling system and control panel with emergency stop functionality. Regular maintenance would follow the manufacturer's guidelines to ensure proper functioning of the sealed-off CO2 gas tube and optical components.