FDA.report

MicroCurrent Face-Lifter 6 in 1

Primary DI
04099702079496
Brand
MicroCurrent Face-Lifter 6 in 1
Company
GESKE Beauty Tech GmbH
Model
Black
Device description
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications

CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions

SubmissionSupplement
K250361000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250361000SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1Geske Beauty Tech GmbH2025-05-23NFO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04099702079496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04099702079496040997020794964099702079496

GMDN Terms

TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
314783822
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04099702078543MicroCurrent Face-Lift Pen 6 in 1Starlight2025-06-05
04099702078604MicroCurrent Face-Lift Pen 6 in 1Black2025-06-05
04099702078666MicroCurrent Face-Lift Pen 6 in 1Gray2025-06-05
04099702078727MicroCurrent Face-Lift Pen 6 in 1Green2025-06-05
04099702078789MicroCurrent Face-Lift Pen 6 in 1Hello Kitty Pink2025-06-05
04099702079380MicroCurrent Face-Lift Pen 6 in 1White2025-06-05
04099702079397MicroCurrent Face-Lift Pen 6 in 1Magenta2025-06-05
04099702079403MicroCurrent Face-Lift Pen 6 in 1Aquamarine2025-06-05
04099702079410MicroCurrent Face-Lift Pen 6 in 1Turquoise2025-06-05
04099702079427MicroCurrent Face-Lift Pen 6 in 1Pink2025-06-05
04099702079434MicroCurrent Face-Lift Pen 6 in 1Purple2025-06-05
04099702079441MicroCurrent Face-Lift Pen 6 in 1Midnight2025-06-05
04099702079472MicroCurrent Face-Lifter 6 in 1Starlight2025-06-05
04099702079519MicroCurrent Face-Lifter 6 in 1Gray2025-06-05
04099702079618MicroCurrent Face-Lifter 6 in 1Green2025-06-05
04099702079632MicroCurrent Face-Lifter 6 in 1Magenta2025-06-05
04099702080331MicroCurrent Face-Lift Pen 6 in 1Hello Kitty Purple2025-06-05

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00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
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00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDNFO2025-08-07
00817076014516bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
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04099702078543MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702078604MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702078666MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702078727MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702078789MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702079380MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702079397MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05