FDA.reportPublic FDA data

Theraray

Primary DI
08906172600081
Brand
Theraray
Company
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
Model
THERA-HAN-14
Device description
Red & Infrared light phototherapy unit
Published
2025-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906172600081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906172600081089061726000818906172600081

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, wearableA patient-worn, battery-powered device assembly intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., joint pain), and to improve blood circulation in these areas. It consists of a device with an integrated light with a controller; the light is intended to be attached to a specific body part (e.g., back, knee) and may include devices (e.g., adhesive pad) to allow attachment.

Regulatory Flags#

DUNS number
854329477
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09361725024414Bon ChargeT-119-HRC-BC2025-11-28
08906172600074LightdoctorTUR-HAN-142025-10-10
00731093154485CurrentBody™ZLD-110A2025-06-23
00810025928476Caring Mill CM-HD-05-I2025-06-25
00810025927806Caring MillCM-ZLD-80-MP2025-01-30
00857563004965DPLZLD-60SAN.A.2022-02-10
00843041125826Tommie CopperTC-ZLD-60V-BW2025-02-15
00843041125833Tommie CopperTC-HX-60B-JW2025-02-15
00843041125840Tommie CopperTC-ZLD-46-NP2025-02-15
00843041125857Tommie CopperTC-ZLD-60-X-SW2025-02-15
00843041143172Tommie CopperTC-ST-58-HM2025-02-15
00810025926953Caring MillCM-ZLD-602024-03-16
00810025926960Caring MillCM-ZLD-60-BP2024-03-16
00810025926977Caring MillCM-ZLD-60-NW2024-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
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B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.ILY2026-05-02
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.ILY2026-01-16
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
00810071230509RegenalaseIPG Medical CorporationILY2025-06-09
00810071230516RegenalaseIPG Medical CorporationILY2025-06-09
00810071230530RegenalaseIPG Medical CorporationILY2025-06-09
16978368600013 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600020 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600037 LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05
16978368600044LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2025-06-05