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Surgical Ho:YAG laser system - ARTG 382650

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 registered under ARTG number 382650 and 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.

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Class IIb
ARTG 382650
Class IIb
Surgical Ho:YAG laser system
ARTG ID: 382650
Good Name: Innologic Pty Ltd - Surgical Ho:YAG laser system
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
382650
Start Date
January 14, 2022
Effective Date
January 14, 2022
Manufacturer
Country
Germany
Address
Brusseler Strasse 10, Jena, 07747