FDA.reportPublic FDA data

C-Wave LED Mask for Neck & Décolleté

Primary DI
05060534510999
Brand
C-Wave LED Mask for Neck & Décolleté
Company
I-SMART DEVELOPMENTS LIMITED
Model
TN2037
Device description
C-Wave LED Mask for Neck & DécolletéBeauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device)
Published
2024-11-11
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
05060534510999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060534510999050605345109995060534510999

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit131 Degrees Fahrenheit

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
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
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
05060534510807Omnilux Blemish EraserTN21972023-10-26
05060534510814Omnilux Eye BrightenerTN21892023-10-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
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