FDA.reportPublic FDA data

Omnilux Men's

Primary DI
05060534510524
Brand
Omnilux Men's
Company
I-SMART DEVELOPMENTS LIMITED
Model
TN2227
Device description
Omnilux Men's Facemask Device (Red & NIR).
Published
2022-10-24
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060534510524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060534510524050605345105245060534510524

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
Handling Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
223616320
Device count
1
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
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
05060534510807Omnilux Blemish EraserTN21972023-10-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347BDRCKED0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
B347TB202400000TABLED TECHNOLOGIES INCILY2026-04-23
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOHS2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdILY2026-02-06
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorBTL INDUSTRIES LIMITEDILY2025-11-19
G180DIOWAVESTEALTHLIT0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12