Skip to content

Multiple CO2 Laers

by Mattioli Engineering, Srl

510(k) K941838

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 NumberK941838 Date15 Dec 1994ClearedStatusActive

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  • Withdrawn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 Multiple CO2 Lasers is a medical device manufactured by Mattioli Engineering, Srl. This device is classified under product code GEX and was cleared by the FDA through a 510(k) process on December 15, 1994.

The device is intended for use in general and plastic surgery applications. It is supplied by Mattioli Engineering, Srl located in Florence, Italy. The device has model number K941838 and is authorized for use in the United States.

Other devices from Mattioli Engineering Corp.

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 Multiple CO2 Lasers device used for?

    The Multiple CO2 Lasers is a medical device intended for use in general and plastic surgery applications. It is manufactured by Mattioli Engineering, Srl and has model number K941838.

  • How is the Multiple CO2 Lasers supplied?

    The device is supplied by Mattioli Engineering, Srl located in Florence, Italy. The manufacturer's address is Viale Machiavelli, 2/A, Florence, Italy, postal code 50125.

  • What is the regulatory status of the Multiple CO2 Lasers?

    The Multiple CO2 Lasers is classified under product code GEX and was cleared by the FDA through a 510(k) process on December 15, 1994. It is authorized for use in the United States.

  • Is the Multiple CO2 Lasers a single-use or reusable device?

    The device data does not specify whether the Multiple CO2 Lasers is designed for single-use or multiple uses. For specific usage instructions, please refer to the manufacturer's documentation or contact Mattioli Engineering, Srl directly.