FDA.report

Therapy Light

Primary DI
06977863220163
Brand
Therapy Light
Company
E.SHINE LIGHTING CO., LIMITED
Model
BIOMAXPRO GRANDE
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

Related Records

Product Codes

CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications

CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06977863220163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06977863220163069778632201636977863220163

GMDN Terms

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

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 DIBrandModelCatalogPublished
06977863220149Therapy LightBIOMAXPRO NANO2026-03-02
06977863220156Therapy LightBIOMAXPRO MIDI2026-03-02
06977863220170Therapy LightBIOMAXPRO ULTRA2026-03-02
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

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