FDA.reportPublic FDA data

EOS X by Deesse Pro

Primary DI
05060534510401
Brand
EOS X by Deesse Pro
Company
I-SMART DEVELOPMENTS LIMITED
Model
TN2214
Device description
EOS X by Deesse ProBlue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214103000Shani Darden LED light therapy maskHarpar Grace International2022-03-22OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060534510401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060534510401050605345104015060534510401

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

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
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
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06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
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