FDA.reportPublic FDA data

Préime DermaFacial

Primary DI
05391540830871
Brand
Préime DermaFacial
Company
EMA AESTHETICS LIMITED
Model
Console
Published
2025-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243072000Préime DermaFacial (MicroT)EMA Aesthetics , Ltd.2025-04-01NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391540830871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391540830871053915408308715391540830871

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985737841
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391540830826Préime DermaFacialAquaB2025-09-15
05391540830833Préime DermaFacialVibroX2025-09-15
05391540830840Préime DermaFacialMicroT2025-08-07
05391540830857Préime DermaFacial Collagen+2025-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
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
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDNFO2025-08-07
00817076014516bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014523bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014530bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
08908008085499Syrma Johari MedTech LimitedSYRMA JOHARI MEDTECH LIMITEDNFO2025-07-08
16974667825010JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
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16974667825034JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
16974667825041JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
16974667825058JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
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04099702079380MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
04099702079397MicroCurrent Face-Lift Pen 6 in 1GESKE Beauty Tech GmbHNFO2025-06-05
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