AURA

Basic Information

• Brand Name: AURA
• Primary DI: 07290016586817
• Version / Model: Model VXU-301
• Catalog Number: 34693000ND-US
• Company Name: POLLOGEN LTD
• Labeler DUNS: 514905681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-22
• Public Version: 2
• Public Version Date: 2026-03-31
• Public Version Status: Update
• Public Device Record Key: 6a3e8606-fe9a-4d81-8fa8-9b0b9682a9a9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	878.4420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44832	Multi-modality skin/body contouring system	An assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016586817	GS1