Australia TGA ARTG record

Cosmetic phototherapy system, home-use

Australia TGA ARTG Registered Device · Ergo Health Group Pty Ltd · Shenzhen Kaiyan Medical Equipment Co Ltd · Class IIa · Started January 31, 2024

Good Name: Ergo Health Group Pty Ltd - Cosmetic phototherapy system, home-use

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 31, 2024
Effective Date: January 31, 2024

Sponsor

Name: Ergo Health Group Pty Ltd

Manufacturer

Name: Shenzhen Kaiyan Medical Equipment Co Ltd
Country: China
Address: Building #3 and Building #5 40th of Fuxin Street Huaide Community Fuyong Town, Baoan District Shenzhen, Guangdong, 518103

Intended purpose

Device is a non-invasive phototherapy device used on Face, neck and lower neckline region designed to emit LED light (wavelength range of 470nm to 1072nm) in the visible and invisible spectra for the cosmetic treatment of dermatological conditions in the home or in beauty salons. The LED device is intended for skin repair, skin rejuvenation, reduction of wrinkles, redness, pigmentation, scarring, sun damage, dullness, blemishes and inflammation.

About this record

Access comprehensive regulatory information for Cosmetic phototherapy system, home-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ergo Health Group Pty Ltd, manufactured by Shenzhen Kaiyan Medical Equipment Co Ltd in China. The device registration started on January 31, 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.