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Dermatological carbon dioxide laser system

Access comprehensive regulatory information for Dermatological carbon dioxide laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by CSHE Australia Pty Ltd, manufactured by WON Tech Co Ltd in South Korea. The device registration started on September 15, 2017.

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
Class IIb
Dermatological carbon dioxide laser system
Australia TGA ARTG Registered Device
Good Name: CSHE Australia Pty Ltd - Dermatological carbon dioxide laser system
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Intended Purpose

Laser surgery device intended to be used for superficial fractional treatments in the epidermis and dermis, for superficial ablation and deeper tissue coagulation and in the treatment of skin tightening, scar management, reducing acne scarring, inflammatory acne vulgaris and pigment lesion removal. Used for Incision, Excision, Ablation and Vaporization of Soft Tissue.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 15, 2017
Effective Date
September 15, 2017
Manufacturer
Country
South Korea
Address
64 Techno 8-ro Yuseong-gu, Daejeon, 34025