FDA.reportPublic FDA data

Dp Dermaceuticals L.E.D. HAND

Primary DI
05060534510227
Brand
Dp Dermaceuticals L.E.D. HAND
Company
I-SMART DEVELOPMENTS LIMITED
Model
TN19S
Catalog number
125A
Device description
LED Glove Device- DP Dermaceuticals Branded
Published
2021-05-05
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
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
05060534510227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060534510227050605345102275060534510227

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
223616320
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060534511521ELEMIS Red Light MaskTN23322026-08-07
05060534511231PRIORI Next Generation LED FacemaskTN23322026-03-31
05060534511156The Dynamo Deep LED Collagen-Boosting MaskTN23322025-08-21
05060534511163Light therapy LED facemask from City BeautyTN20102025-08-15
05060534510982Dp DERMACEUTICALS L.E.D.+ FACETN23322025-04-07
05060534511064UKSKIN LED Dual Light Pro-Therapy Face MaskTN20102025-01-31
05060534510944Glo MaskTN23322025-01-27
05060534511002QMS Derma Expert FacemaskTN23322025-01-27
05060534511071Beauty Pie C -WAVE REJUVENATING LED TREATMENT FOR HANDSTN19S125A2025-01-22
05060534510968SMOOTHSKIN DuoLux LED Facemask TN20102024-08-22
05060534510999C-Wave LED Mask for Neck & DécolletéTN20372024-11-11
05060534510951SMOOTHSKIN DuoLux Mini Collagen+ LED Eye PatchesTN21892024-08-22
05060534510906Beauty Pie C-Wave Light Facial MaskTN20102024-06-07
00628011719911North American Kandyway Eternal Glow MD-FaceTN19G111B2024-05-06
05060534510838Dr Sabrina Eye Regenerate LED maskTN21892024-05-06
00628011719515Kandyway Eternal Glow MD - FaceTN19G111B2022-09-28
05060534510401EOS X by Deesse ProTN22142024-01-23
05060534510685Luma BlemishTN21972023-10-26
05060534510692Luma ReviveTN21892023-10-26
05060534510746Lightmax mini pro Eyeconic LEDTN21892023-10-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
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06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
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00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
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08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27