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Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - ARTG 443973

Access comprehensive regulatory information for Dermatological Nd:YAG/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 registered under ARTG number 443973 and sponsored by Esthetica Academy, manufactured by AMI Inc in South Korea. The device registration started on March 19, 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 443973
Class IIb
Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
ARTG ID: 443973
Good Name: Esthetica Academy - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
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Intended Purpose

Intended to be used for the treatment of pigmented lesions including those caused by cell or blood vessel rupture, melasma, Otaโ€™s nevus, xanthelasma palpebrarum, dyschromatosis universalis hereditaria, red nevus, partial unilateral lentiginosis, cafe au lait spots, Beckerโ€™s nevus.

Device Classification
Risk Class
Class IIb
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
443973
Start Date
March 19, 2024
Effective Date
March 19, 2024
Manufacturer
Country
South Korea
Address
RM 1407, 1408, 1409 SJ Techno Ville 278 Beotkkot-ro, Geumcheon-gu, Seoul, 08511