FDA.reportPublic FDA data

Elevare

Primary DI
00850001456678
Brand
Elevare
Company
Omm Imports Inc.
Model
E800
Device description
Over the counter red/IR device for the treatment of wrinkles.
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001456678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001456678008500014566788500014566780850001456678

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.

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
00850001456647Genesis SkyeGSKYE2024-08-28
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

Other Devices Sharing Product Codes#

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
06980088700006KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990143NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990167NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990174NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990181NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06974958310549ideatherapyShenzhen Idea Light LimitedOHS2026-04-17
06974958310556LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06974958310563LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07