FDA.reportPublic FDA data

Glo Mask

Primary DI
05060534510944
Brand
Glo Mask
Company
I-SMART DEVELOPMENTS LIMITED
Model
TN2332
Device description
Glo MaskRebrand of Luma Pro Facemask (TN2332)- Indicated for Wrinkles.
Published
2025-01-27
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191629000faceLITEIsmart Marketing Svcs, Ltd.2019-09-12OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060534510944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060534510944050605345109445060534510944

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 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
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
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
05060534510814Omnilux Eye BrightenerTN21892023-10-26

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