Australia TGA ARTG record

Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system

Australia TGA ARTG Registered Device · Ultradent Australia Pty Ltd · Azena Medical LLC · Class I · Started June 14, 2019

Good Name: Ultradent Australia Pty Ltd - Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system

Device classification

Risk Class: Class I
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: June 14, 2019
Effective Date: June 14, 2019

Sponsor

Name: Ultradent Australia Pty Ltd

Manufacturer

Name: Azena Medical LLC
Country: United States of America
Address: 3021 Citrus Circle ,Ste 180, Walnut Creek, California, 94598

Intended purpose

The intended use of the PBM Adapter is to allow the Gemini Laser to provide near-infrared laser energy to a tissue surface for the purpose of photobiomodulation

About this record

Access comprehensive regulatory information for Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Ultradent Australia Pty Ltd, manufactured by Azena Medical LLC in United States of America. The device registration started on June 14, 2019.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.