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Fractional CO2 Laser - General/multiple surgical carbon dioxide laser system - ARTG 413444

Access comprehensive regulatory information for Fractional CO2 Laser - General/multiple surgical carbon dioxide 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 413444 and 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
ARTG 413444
Class IIb
Fractional CO2 Laser - General/multiple surgical carbon dioxide laser system
ARTG ID: 413444
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Fractional CO2 Laser - General/multiple surgical carbon dioxide laser system
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Intended Purpose

Fractional Mode: This device is used to treat acne scars through the coagulation of tissues. General Mode: This device is used to remove warts through the ablation of tissues.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
413444
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