Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Esthetica Academy · AMI Inc · Class IIb · Started March 19, 2024

Good Name: Esthetica Academy - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system

Device classification

Risk Class: Class IIb
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: March 19, 2024
Effective Date: March 19, 2024

Sponsor

Name: Esthetica Academy

Manufacturer

Name: AMI Inc
Country: South Korea
Address: RM 1412 SJ Techno Ville 278 Beotkkot-ro Geumcheon-gu, Seoul

Intended purpose

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

About this record

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 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.