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Giant Laser Cluster 3

by Thor Photomedicine Inc.

Part of a family of 14 devices: see the family page

Ref S2195

Giant Laser Cluster 3 is a red-light phototherapy unit (EU MDR Class IIb; FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Thor Photomedicine Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 506049413LX2SYSTEMJW) with CE/MDR certificate 2026-MDR/QS-016 valid until 20 Feb 2031, cleared under FDA 510(k) K033923 on 17 Mar 2004 and listed in FDA GUDID since 7 May 2026 (UDI-DI 05060494130718), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

20 Feb 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

510(k) K033923

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506049413LX2SYSTEMJW Basic UDI-DI 05060494130718UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060494130718 UDI-DI Date7 May 2026ListedStatusListed 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 506049413LX2SYSTEMJW registered 28 May 2026 Active· +1 more in the status table
  • FDA 510(k) K033923 decided 17 Mar 2004 Active
  • FDA GUDID UDI-DI 05060494130718 listed 7 May 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-016 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    20 Feb 2026
    Expires
    20 Feb 2031

Timeline

5 dated events

  1. Cleared FDA 510(k) K033923
  2. Certificate issued EUDAMED 2026-MDR/QS-016
  3. Listed FDA GUDID 05060494130718
  4. Registered EUDAMED 506049413LX2SYSTEMJW
  5. Certificate expires EUDAMED 2026-MDR/QS-016

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  • Withdrawn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
Giant Laser Cluster
Generic name
Red-light phototherapy unit, professional
Device name
LX2.3
Model / reference
S2195 EUDAMED
3 GUDID
Primary DI / UDI-DI
05060494130718
Basic UDI-DI
506049413LX2SYSTEMJW
Direct marketing DI
05060494130718
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
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
S2195
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

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

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

    Class II

  • 810nm 450mW Standard Tip B/G 2.0

    Class II

See all devices from Thor Photomedicine Inc. →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)