FDA.report

Préime DermaFacial

Primary DI
05391540830833
Brand
Préime DermaFacial
Company
EMA AESTHETICS LIMITED
Model
VibroX
Published
2025-09-15
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
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05391540830833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05391540830833053915408308335391540830833

GMDN Terms

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

Regulatory Flags

DUNS number
985737841
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
05391540830826Préime DermaFacialAquaB2025-09-15
05391540830871Préime DermaFacial Console2025-09-15
05391540830840Préime DermaFacialMicroT2025-08-07
05391540830857Préime DermaFacial Collagen+2025-08-07

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08800250280694QuadtheraECO DM LAB Co., Ltd.ISA2026-02-16
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04262477320197SONOGELE.M.S. Electro Medical Systems S.A.ISA2025-09-02
08809939930691CareCellve Wave PlusGeneral Bio Co., Ltd.ISA2025-09-02