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B.Light Clear Evo

by BEMER Int. AG

Ref 434500, 434600

B.Light Clear Evo (434500) is a medical device (EU MDR Class IIa; FDA Class II) made by Bemer Int. AG, registered in EUDAMED on 29 Sep 2025 (Basic UDI-DI 764016146LIGHTB3), cleared under FDA 510(k) K223919 on 23 Sep 2023 and listed in FDA GUDID since 5 Mar 2025 (UDI-DI 07640161460195), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223919

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764016146LIGHTB3 Basic UDI-DI Date29 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07640161460195 UDI-DI Date5 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223919 Date23 Sep 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764016146LIGHTB3 registered 29 Sep 2025 Active
  • FDA 510(k) K223919 decided 23 Sep 2023 Active
  • FDA GUDID UDI-DI 07640161460195 listed 5 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223919
  2. Listed FDA GUDID 07640161460195
  3. Registered EUDAMED 764016146LIGHTB3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
B.Light Clear Evo
B.Light Restore Evo
Generic name
Light-energy skin surface treatment system applicator
Device name
Light Applicators
Model / Ref / Catalog
434500, 434600, BEMER Therapy System Evo
Primary DI / UDI-DI
07640161460195, 07640161460201
Basic UDI-DI
764016146LIGHTB3
Direct marketing DI
07640161460195
07640161460201
510(k) Number
FDA product code
OHS, OLP
EMDN code
Z12040202, Z12040203
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
434500
434600
GUDID
BEMER Therapy System Evo
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
LI-MF-000002555

Related devices

Category: Red-light phototherapy unit, professional

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Properties

  • Over-the-counter
  • Serial number
Other properties (23, all answered No)