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Finebeam

by Snj Co., Ltd

510(k) K202288Ref SNJ-UM-007Model Finebeam

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202288↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800086000015 Basic UDI-DI 08800086000015UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800086000015 UDI-DI Date3 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202288 Date19 Nov 2021ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800086000015 registered 18 Mar 2026 Active
  • FDA 510(k) K202288 decided 19 Nov 2021 Active
  • FDA GUDID UDI-DI 08800086000015 listed 3 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202288
  2. Listed FDA GUDID 08800086000015
  3. Registered EUDAMED B-08800086000015

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Dermatological frequency-doubled solid-state laser system
Device name
Nd:YAG Surgical Laser
Model / reference
Finebeam, SNJ-UM-007
FDA applicant
SNJ Co., Ltd.
Primary DI / UDI-DI
08800086000015
Basic UDI-DI
B-08800086000015
510(k) Number
FDA product code
GEX
EMDN code
Z12011017 Neodymium surgical laser
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 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.

Devices cleared under K202288

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K202288
UDI-DISize and differences
Finebeam
SNJ CO., LTD
Finebeam08800086000077 —On the market
Finebeam
SNJ CO., LTD
Finebeam08800086000015 —On the market

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

Other devices from Snj Co., Ltd

  • Finebeam

    Class II

  • N-Pulse FX

    Class IIb

  • Finexel

    Class IIb

Properties

  • Serial number
Other properties (22, all answered No)