Australia TGA ARTG record

Surgical Ho:YAG laser system

Australia TGA ARTG Registered Device · Innologic Pty Ltd · Asclepion Laser Technologies GmbH · Class IIb · Started January 14, 2022

Good Name: Innologic Pty Ltd - Surgical Ho:YAG laser system

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 14, 2022
Effective Date: January 14, 2022

Sponsor

Name: Innologic Pty Ltd

Manufacturer

Name: Asclepion Laser Technologies GmbH
Country: Germany
Address: Brusseler Strasse 10, Jena, 07747

Intended purpose

A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a doped glass/crystal medium to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates/morcellates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

About this record

Access comprehensive regulatory information for Surgical Ho:YAG laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Innologic Pty Ltd, manufactured by Asclepion Laser Technologies GmbH in Germany. The device registration started on January 14, 2022.

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.