FDA.reportPublic FDA data

Large LED Cluster

Primary DI
05060494130725
Brand
Large LED Cluster
Company
THOR PHOTOMEDICINE LIMITED
Model
3
Device description
S2140 Large LED Cluster
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033923000TH0R DDII IR LAMP SYSTEMThor Intl.2004-03-17ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060494130725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060494130725050604941307255060494130725

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

Regulatory Flags#

DUNS number
856233908
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060494130664NIR Acutip Laser32026-05-07
05060494130671Trigger Point Laser32026-05-07
05060494130688Red Acutip Laser32026-05-07
05060494130695Red Laser22026-05-07
05060494130701Laser Cluster22026-05-07
05060494130718Giant Laser Cluster32026-05-07
05060494130732Medium LED Cluster32026-05-07
05060494130749Small LED Cluster32026-05-07
05060494130756Trigger Point Handpiece22026-05-07
0506049413063369 LED Cluster issue 332025-07-31
0506049413064019 LED Cluster issue 332025-07-31
05060494130657104 LED Cluster issue 332025-07-31
05060494130619810nm 200mW NIR Light Guide Laser2.02025-07-15
05060494130626660nm 75mW Red Light Guide Laser1.02025-07-15
05060494130589LED Helmet2.32021-10-06
05060494130596LED Helmet PRX2.32021-10-06
05060494130572LED Lollipop2.32021-10-01
05060494130541Lollipop Probe2.32021-05-17
05060494130558810nm 16W Cluster PRX100 (80x200mW)2.32021-05-17
05060494130565PRX Lollipop Probe2.32021-05-17

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