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104 LED Cluster issue 3

by Thor Photomedicine Inc.

104 LED Cluster issue 3 is a red-light phototherapy unit (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Thor Photomedicine Inc., cleared under FDA 510(k) K033923 on 17 Mar 2004 and listed in FDA GUDID since 31 Jul 2025 (UDI-DI 05060494130657), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K033923

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060494130657 UDI-DI Date31 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033923 Date17 Mar 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033923 decided 17 Mar 2004 Active
  • FDA GUDID UDI-DI 05060494130657 listed 31 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033923
  2. Listed FDA GUDID 05060494130657

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Red-light phototherapy unit, professional
Model / reference
3
Primary DI / UDI-DI
05060494130657
510(k) Number
FDA product code
ILY
GMDN term
Red-light phototherapy unit, professional
Device class
Class II
Regulation number
890.5500
GUDID distribution status
In Commercial Distribution

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 Red-light phototherapy unit, professional.

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

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)