Skip to content

Prometey Model G1-03

by Spectrum International

510(k) K062071

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 NumberK062071 Date28 Sep 2006ClearedStatusActive

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  • Withdrawn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, 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 Prometey Model G1-03 is a soft tissue diode laser system designed for surgical procedures within the oral cavity. It utilizes solid-state laser diodes to generate an 810 nm wavelength with a maximum power output of 3 Watts.

This device is supplied by Spectrum International and has received FDA 510(k) clearance. It is categorized under the product code GEX for use in general and plastic surgery applications.

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 primary clinical application for the Prometey G1-03?

    The Prometey G1-03 is a soft tissue diode laser system specifically designed for performing surgical procedures within the oral cavity.

  • What are the technical specifications of the laser output?

    This device utilizes solid-state laser diodes to generate an 810 nm wavelength, providing a maximum power output of 3 Watts for surgical use.

  • What is the regulatory status of this device?

    The Prometey G1-03 has received FDA 510(k) clearance under the product code GEX, which covers its use in general and plastic surgery applications.