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Dermatological laser beam producing handpiece - ARTG 482285

Access comprehensive regulatory information for Dermatological laser beam producing handpiece in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 482285 and sponsored by Aussie Medi Tech Pty Ltd, manufactured by Quanta System SPA in Italy. The device registration started on March 12, 2025.

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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TGA ARTG Official Data
Class IIb
ARTG 482285
Class IIb
Dermatological laser beam producing handpiece
ARTG ID: 482285
Good Name: Aussie Medi Tech Pty Ltd - Dermatological laser beam producing handpiece
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Intended Purpose

Twain 2940 The Twain 2940 (2940 nm Er:YAG laser handpiece) is intended for incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue for general surgery in medical specialties including plastic surgery, aesthetic medicine, dermatology and podiatry. It is indicated for both fractional and traditional ablative skin resurfacing procedures and benign cutaneous lesions treatment. 2940 nm Fractional: Fractional skin resurfacing (wrinkle and fine line removal, deeper wrinkle correction, sun and age spotsโ€™ reduction, acne and traumatic scarsโ€™ removal and dyschromia removal. 2940 nm Normal: Coagulation, ablation, vaporization of soft tissue. Full ablative skin resurfacing

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482285
Start Date
March 12, 2025
Effective Date
March 12, 2025
Manufacturer
Country
Italy
Address
Via Acquedotto 109, Samarate, VA, 21017