AURA 34693000ND-US

GUDID 07290016586817

POLLOGEN LTD

Multi-modality skin/body contouring system

• Primary Device ID: 07290016586817
• NIH Device Record Key: 6a3e8606-fe9a-4d81-8fa8-9b0b9682a9a9
• Commercial Distribution Discontinuation: 2026-02-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AURA
• Version Model Number: Model VXU-301
• Catalog Number: 34693000ND-US
• Company DUNS: 514905681
• Company Name: POLLOGEN LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016586817 [Primary]

FDA Product Code

• PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-22

Devices Manufactured by POLLOGEN LTD

• 07290016586794 - MyLift: 2026-03-02
• 07290016586817 - AURA: 2026-03-02
• 07290016586817 - AURA: 2026-03-02
• 07290016586565 - Applicator 3: 2026-02-10
• 07290016586572 - Applicator VO: 2026-02-10
• 07290016586763 - triLift FACE: 2026-02-10 The device is a software-controlled capital equipment platform that enables application of radiofrequency (RF) energy onto the s
• 07290016586770 - Applicator 1: 2026-02-10
• 07290016586787 - Applicator 2: 2026-02-10
• 07290016586671 - GENEO, GLO2FACIAL, ELITE: 2025-02-19 RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA C