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Surgical Ho:YAG laser system - ARTG 464605

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 464605 and sponsored by Coloplast Pty Ltd, manufactured by Quanta System SPA in Italy. The device registration started on October 15, 2024.

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 464605
Class IIb
Surgical Ho:YAG laser system
ARTG ID: 464605
Good Name: Coloplast Pty Ltd - Surgical Ho:YAG laser system
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Intended Purpose

The Coloplast TFL Drive laser device and its accessories are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and lithotripsy of stones in use in medical specialties including: Urology, Thoracic and Pulmonary, ENT, Neurosurgery, Gastroenterology, Gynecology and General Surgery.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464605
Start Date
October 15, 2024
Effective Date
October 15, 2024
Manufacturer
Country
Italy
Address
Via Acquedotto 109, Samarate, VA, 21017