FDA.reportPublic FDA data

Micro-current Facial Beauty Device

Primary DI
06976415770170
Brand
Micro-current Facial Beauty Device
Company
Shenzhen Aozemei Technology Co., Ltd.
Model
AM-812B
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
OTC
true

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
06976415770170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976415770170069764157701706976415770170

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation probeA non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.

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
06976415770187Micro-current Facial Beauty DeviceAM-812W2025-04-01

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Primary DI, Brand, Company table
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00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
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06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
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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00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02