# Finebeam

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/finebeam-gex>
- Manufacturer: [Snj Co., Ltd](https://devicerts.com/manufacturers/snj-co-ltd) (South Korea)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: GEX
- EMDN: Z12011017 NEODYMIUM SURGICAL LASER
- GMDN: Dermatological frequency-doubled solid-state laser system (47877)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Finebeam Dual Q-Switched and Long-Pulse Nd:YAG Laser System is a dual-mode laser device designed for dermatological and plastic surgery applications. It combines Q-switched and long-pulsed laser technologies to address a range of skin and vascular conditions, including pigmentation disorders, tattoos, and vascular lesions.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings by trained professionals. It is classified under the Product Code GEX and has received FDA 510(k) clearance and MDD authorization, ensuring compliance with regulatory standards. The system requires proper maintenance and storage as outlined in manufacturer guidelines to ensure safety and performance.

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08800086000015 · UDI-DI 08800086000015 · registered 2026-03-18 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08800086000015 · listed 2023-05-03 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K202288 · decision 2021-11-19 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Dermatological frequency-doubled solid-state laser system [FDA GUDID (AccessGUDID)]
- Device name: Nd:YAG Surgical Laser [EUDAMED]
- Model / reference: Finebeam [EUDAMED, FDA GUDID (AccessGUDID)]; SNJ-UM-007 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08800086000015 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-08800086000015 [EUDAMED]
- 510(k) Number: K202288 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: GEX [FDA 510(k), FDA GUDID (AccessGUDID)]
- EMDN code: Z12011017 [EUDAMED]
- GMDN term: Dermatological frequency-doubled solid-state laser system (47877) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k), FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Spain [EUDAMED]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Finebeam, Snj Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/finebeam-gex (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/finebeam-gex.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/finebeam-gex
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.