FDA.reportPublic FDA data

Therapy Light

Primary DI
06977863220170
Brand
Therapy Light
Company
E.SHINE LIGHTING CO., LIMITED
Model
BIOMAXPRO ULTRA
Device description
This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
06977863220170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977863220170069778632201706977863220170

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547460611
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977863220149Therapy LightBIOMAXPRO NANO2026-03-02
06977863220156Therapy LightBIOMAXPRO MIDI2026-03-02
06977863220163Therapy LightBIOMAXPRO GRANDE2026-03-02
06977863220019Therapy LightRDPRO3002025-04-09
06977863220026Therapy LightRDPRO7502025-04-09
06977863220033Therapy LightRDPRO10002025-04-09
06977863220040Therapy LightRDPRO15002025-04-09
06977863220101Therapy LightBIOMAX3002025-04-09
06977863220118Therapy LightBIOMAX4502025-04-09
06977863220125Therapy LightBIOMAX6002025-04-09
06977863220132Therapy LightBIOMAX9002025-04-09
06977863220200Therapy LightRouge Tabletop2025-04-09
06977863220217Therapy LightRouge Pro2025-04-09
06977863220224Therapy LightRouge Max2025-04-09
06977863220231Therapy LightRouge Ultimate2025-04-09
06977863220309Therapy LightHelsi Mini2025-04-09
06977863220316Therapy LightHelsi Plus2025-04-09
06977863220323Therapy LightHelsi Pro2025-04-09
06977863220330Therapy LightHelsi Max2025-04-09
06977863220408Therapy LightSolace 3002025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09361725008346BON CHARGELight Tree Ventures Europe B.V.ILY2026-05-25
09361725008360BON CHARGELight Tree Ventures Europe B.V.ILY2026-05-25
06976812430219TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06976812430226TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06976812430233TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06977863220149Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220156Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220163Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06979292890009SummusLasxbot (Shenzhen) Robot Co., LtdILY2026-02-27
08500723550001SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550018SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550025SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550049SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550056SunPowerLEDKERBER USA INC.ILY2026-02-26
08500723550063SunPowerLEDKERBER USA INC.ILY2026-02-26
00840397513284Sharper ImageMerchsource, LLCILY2026-02-17
06977782490005Quasar MDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-02-11
06978181510325QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-10
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06956822893020SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06956822893037SolawaveShenzhen Goodwind technology development Co.,LtdILY2026-02-04
06978181510301QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06978181510318QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06979812520034MarrisJjwXiamen Langxing Medical Technology Co., Ltd.ILY2026-01-26
06979322350015N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350022N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350039N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350046N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350053N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
06979322350060N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22