FDA.reportPublic FDA data

Heated Eye Pad

Primary DI
B172HEP10
Brand
Heated Eye Pad
Company
DIGITAL HEAT CORPORATION
Model
Heated Eye Pad
Device description
Heated Eye Pad Ophthalmic Warmer
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B172HEP10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye heat therapy packA non-sterile device intended to be placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which contains a heat-retaining substance intended to be heated in a microwave oven prior to use. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080250040
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B172OTH10OCuSOFT Thermal 1-TouchOCuSOFT Thermal 1-Touch2019-10-10
B172TH10Thernal 1-TouchThernal 1-Touch2019-08-08
B172PRO0Heated Eye Pad ProHeated Eye Pad Pro2019-04-15
B172SC10Scorpion 1-TouchScorpion 1-Touch2018-08-07

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Primary DI, Brand, Company table
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00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
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00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
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