FDA.reportPublic FDA data

Micro-current Facial Beauty Device

Primary DI
06976415770187
Brand
Micro-current Facial Beauty Device
Company
Shenzhen Aozemei Technology Co., Ltd.
Model
AM-812W
Device description
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718)Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Published
2025-04-01
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
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
K241718000
K243430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241718000Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.2024-10-28OHS
K243430000Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.2024-12-19NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976415770187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976415770187069764157701876976415770187

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
412088514
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976415770156Micro-current Facial Beauty DeviceAM-810B2025-04-01
06976415770163Micro-current Facial Beauty DeviceAM-810W2025-04-01
06976415770170Micro-current Facial Beauty DeviceAM-812B2025-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
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00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
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00810140063090RenphoJoicom CorporationOLP2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
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18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07