Skip to content

19 LED Cluster issue 3

by Thor Photomedicine Inc.

Ref S2131

19 LED Cluster issue 3 is a red-light phototherapy unit (EU MDD Class IIb; FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Thor Photomedicine Inc., registered in EUDAMED on 11 May 2026 (Basic UDI-DI B-05060494130640), cleared under FDA 510(k) K033923 on 17 Mar 2004 and listed in FDA GUDID since 31 Jul 2025 (UDI-DI 05060494130640), active as of 22 Oct 2026.

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) K033923

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060494130640 Basic UDI-DI 05060494130640UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060494130640 UDI-DI Date31 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK033923 Date17 Mar 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05060494130640 registered 11 May 2026 Active
  • FDA 510(k) K033923 decided 17 Mar 2004 Active
  • FDA GUDID UDI-DI 05060494130640 listed 31 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K033923
  2. Listed FDA GUDID 05060494130640
  3. Registered EUDAMED B-05060494130640

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  • Withdrawn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 · GUDID

Trade name
LED Cluster. 850nm & 660nm/370mW 19 diodes. EUDAMED
19 LED Cluster issue 3 GUDID
Generic name
Red-light phototherapy unit, professional
Model / reference
S2131 EUDAMED
3 GUDID
Primary DI / UDI-DI
05060494130640
Basic UDI-DI
B-05060494130640
510(k) Number
FDA product code
ILY
EMDN code
Z12040202 Phototherapy equipment
GMDN term
Red-light phototherapy unit, professional
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5500
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
S2131
GUDID
3
Device classEUDAMED
Class IIb
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 GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Red-light phototherapy unit, professional

Cleared under the same submission (K033923)

and 8 more cleared under K033923

Similar devices in this category

Other devices filed under PHOTOTHERAPY EQUIPMENT.

Other devices from Thor Photomedicine Inc.

  • Red Laser 2

    Class II

  • Laser Cluster 2

    Class II

  • Giant Laser Cluster 3

    Class II

  • 810nm 200mW Acu Tip PRX100 B/G 2.3

    Class II

See all devices from Thor Photomedicine Inc. →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)