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Q-Switched Nd:YAG Laser - Surgical frequency-doubled Nd:YAG laser system

Access comprehensive regulatory information for Q-Switched Nd:YAG Laser - Surgical frequency-doubled Nd:YAG laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by AMI Inc in South Korea. The device registration started on July 13, 2023.

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
Class IIb
Q-Switched Nd:YAG Laser - Surgical frequency-doubled Nd:YAG laser system
Australia TGA ARTG Registered Device
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Q-Switched Nd:YAG Laser - Surgical frequency-doubled Nd:YAG laser system
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Intended Purpose

The Nd:YAG surgical Laser is used in an operating room for the following purpose: Treatment of a pigmented lesions caused by cell or blood vessel rupture, Melasma, Otaโ€™s nevus, Xanthelasma palpebrarum, DUH (Dyschromatosis Universalis Hereditaria), Red nevus, Partial Unilateral Lentiginosis (PUL) Cafe au lait, Beckerโ€™s nevus, etc.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 13, 2023
Effective Date
July 13, 2023
Manufacturer
Country
South Korea
Address
RM 1412 SJ Techno Ville 278 Beotkkot-ro Geumcheon-gu, Seoul