FDA.reportPublic FDA data

Genesis Skye

Primary DI
00850001456647
Brand
Genesis Skye
Company
Omm Imports Inc.
Model
GSKYE
Device description
Over the counter blue LED phototherapy device for the treatment of acne.
Published
2024-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
OTC
true

Product Codes#

Code, Name table
CodeName
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001456647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001456647008500014566478500014566470850001456647

GMDN Terms#

Term, Definition table
TermDefinition
Blue-light phototherapy lamp, home-useA hand-held, battery-powered device designed to emit blue light (e.g., 400-450nm) for phototherapy applications to treat skin diseases such as acne, rosacea, and psoriasis by the patient in the home. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010000704
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001456784MODEL S+ BY SPIRULUX S9002026-05-03
00850001456791PRO MED BY JOUVALLE J9002026-05-02
00850001456746Quantum Q12026-03-02
00850001456739Elevare ONEE900 2025-12-01
00850001456357RelaxatioRX1002022-06-30
00850001456548Perfectio X G2G2-PX2024-10-28
00850001456524Genesis PrimeGP1002024-08-28
00850001456531GlorificoGL222024-08-28
00850001456555Glorifico PlusGL22+2024-08-28
00850001456678ElevareE8002024-08-28
00850001456685Elevare PlusE7502024-08-28
00850001456692Elevare IvoryE5002024-08-28
00850001456708RevvE550R2024-08-28
00850001456715SpiruluxSP8002024-08-28
00850001456456Genesis ZGZ1002022-07-29
00850001456036Perfectio XPX1002022-06-30
00850001456067RecreoR2002022-06-30
00850001456111Juvenis J700B-S2022-06-30
00850001456128JuvenisJ700B-B2022-06-30
00850001456203Sapphire XSX1002022-06-30

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Primary DI, Brand, Company table
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00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
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