FDA.reportPublic FDA data

Préime DermaFacial

Primary DI
05391540830826
Brand
Préime DermaFacial
Company
EMA AESTHETICS LIMITED
Model
AquaB
Published
2025-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391540830826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391540830826053915408308265391540830826

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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391540830833Préime DermaFacialVibroX2025-09-15
05391540830871Préime DermaFacial Console2025-09-15
05391540830840Préime DermaFacialMicroT2025-08-07
05391540830857Préime DermaFacial Collagen+2025-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782384136T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-05-27
08809455602829LHALA JETMETA SYSTEMS CO., LTD.GFE2026-04-23
00860015460653Nextgen Facial MachineT AESTHETICS LLCGFE2026-03-31
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREAHydrafacial LLCGFE2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCGFE2026-03-27
00810007534268Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non Medical)Hydrafacial LLCGFE2026-03-27
08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONALHydrafacial LLCGFE2026-03-13
00850017374225Zaffiro IR Treatment Body ApplicatorNEAUVIA NORTH AMERICA, INC.GFE2026-02-11
00860009525108MediSpaMEDICREATIONS LLCGFE2026-02-11
00817495024622Glace Candela CorporationGFE2025-10-07
00817495025292Glace Candela CorporationGFE2025-10-07
00817495025308Glace Candela CorporationGFE2025-10-07
00817495025315Glace Candela CorporationGFE2025-10-07
00817495025339Glace Candela CorporationGFE2025-10-07
00817495025346Glace Candela CorporationGFE2025-10-07
00817495025353Glace Candela CorporationGFE2025-10-07
00817495025360Glace Candela CorporationGFE2025-10-07
00817495025377Glace Candela CorporationGFE2025-10-07
00817495025384Glace Candela CorporationGFE2025-10-07
00817495025391Glace Candela CorporationGFE2025-10-07
00817495025407Glace Candela CorporationGFE2025-10-07
00817495025414Glace Candela CorporationGFE2025-10-07
00817495025421Glace Candela CorporationGFE2025-10-07
00817495025438Glace Candela CorporationGFE2025-10-07
G050DOXYLIGHTIONIX0OXYLIGHTRAJA MedicalGFE2025-09-24
00810007534756Hydrafacial™ Lip TipHydrafacial LLCGFE2025-07-16
00810007534763HydraScalp™ Tip, Purify, 6-PackHydrafacial LLCGFE2025-07-16
00810007534770HydraScalp™ Tip, Nourish, 6-PackHydrafacial LLCGFE2025-07-16
00198715351606CANLASE-Alexandrite and Nd: Yag laser Canadian Pioneer Medical Technology CorporationGFE2025-07-02