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Fotona Tandem Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022837

by Fotona D.D.

Identifiers

510(k) Number
K022837 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

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

The Fotona Tandem Laser System is a dual-wavelength laser device classified as a General and Plastic Surgery instrument (Product Code: GEX). It is designed for precise tissue interaction, including incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue, as well as permanent hair reduction across Fitzpatrick skin types I-VI.

This system is supplied as a reusable medical device and is intended for use in clinical settings such as surgical and aesthetic procedures. It holds FDA 510(k) clearance (K022837) under the Traditional pathway, with a decision date of November 25, 2002. The device is manufactured by Fotona D.D. in Ljubljana, Slovenia, and adheres to regulatory standards for Class 2 medical devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FOTONA TANDEM LASER SYSTEM (K022837) — FDA 510(k) | Innolitics, K022837 FDA 510(k) - FOTONA TANDEM LASER SYSTEM | Fotona D.D., Dentistry - Home | Fotona, Home | Fotona

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fotona D.D.

Sources (1)

  • FDA 510(k) K022837 24 fields · synced Sep 19, 2026