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Axiom Pulsed Light System

by General Project S.R.L.

510(k) K062312

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 NumberK062312 Date16 Oct 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  • Withdrawn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, 6 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 Axiom Pulsed Light System is an intense pulsed light device used in general and plastic surgery procedures. It is substantially equivalent to the Flash 1 and MedFlash II devices manufactured by General Project.

The system is supplied by General Project S.R.L. and received FDA 510(k) clearance on October 16, 2006 (K062312). It is regulated under product code GEX and was reviewed by the General and Plastic Surgery advisory committee.

Other devices from General Project S.R.L.

Questions

AI-generated answers, 6 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 Axiom Pulsed Light System used for?

    The Axiom Pulsed Light System is an intense pulsed light device designed for use in general and plastic surgery procedures. It is substantially equivalent to the Flash 1 and MedFlash II devices manufactured by General Project.

  • How is the Axiom Pulsed Light System supplied?

    The system is supplied by General Project S.R.L., the manufacturer. The company is located at 56 Westcott Rd., Stamford, CT 06902, with CORNELIA DAMSKY as the contact person.

  • What is the regulatory status of the Axiom Pulsed Light System?

    The Axiom Pulsed Light System received FDA 510(k) clearance on October 16, 2006 (K062312). It is regulated under product code GEX and was reviewed by the General and Plastic Surgery advisory committee.

  • Is the Axiom Pulsed Light System reusable or single-use?

    The device data does not specify whether the Axiom Pulsed Light System is designed for single-use or multiple reuse. This information would be detailed in the device's instructions for use provided by the manufacturer.