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Préime DermaFacial VibroX

by EMA Aesthetics, Ltd.

Préime DermaFacial VibroX is a multi-modality skin surface treatment system (FDA Class I; FDA product code ISA, Massager, Therapeutic, Electric) made by EMA Aesthetics, Ltd., listed in FDA GUDID since 15 Sep 2025 (UDI-DI 05391540830833), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391540830833 UDI-DI Date15 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Préime DermaFacial
Generic name
Multi-modality skin surface treatment system
Model / reference
VibroX
Primary DI / UDI-DI
05391540830833
FDA product code
ISA
GMDN term
Multi-modality skin surface treatment system
Device class
Class I
Regulation number
890.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from EMA Aesthetics, Ltd.

See all devices from EMA Aesthetics, Ltd. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)