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AURA Model VXU-301

by Pollogen Ltd

AURA Model VXU-301 (34693000ND-US) is a Class II device made by Pollogen Ltd, listed in FDA GUDID since 22 Feb 2026 (UDI-DI 07290016586817), 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 Number07290016586817 UDI-DI Date22 Feb 2026ListedStatusListed 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  • Withdrawn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
Aura
Generic name
Multi-modality skin/body contouring system
Model / Ref / Catalog
Model VXU-301, 34693000ND-US
Primary DI / UDI-DI
07290016586817
FDA product code
PAY
GMDN term
Multi-modality skin/body contouring system
Device class
Class II
Regulation number
878.4420
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)