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Dermatological carbon dioxide laser system - ARTG 273658

Access comprehensive regulatory information for Dermatological 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 273658 and sponsored by Ebos Medical Devices Australia Pty Ltd, manufactured by Ilooda Co Ltd in South Korea. The device registration started on March 31, 2016.

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 273658
Class IIb
Dermatological carbon dioxide laser system
ARTG ID: 273658
Good Name: Ebos Medical Devices Australia Pty Ltd - Dermatological carbon dioxide laser system
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Intended Purpose

FRAXIS is a surgical dermatological carbon dioxide laser system used to conduct microfractional laser resurfacing, promoting the reconstruction of both epidermis and dermis. Its uses include the treatment of acne scars, aging skin lesions and various skin renewal and rejuvenation applications. The laser system and its accessories are not intended for gynaecological procedures including but not limited to the treatment of diminished sensation during intercourse; dryness, loss of lubrication and pain during intercourse; vaginal pain or discomfort; vaginal laxity (looseness) and trophy, urinary incontinence and urgency, vaginal itchiness and discomfort, vulva tightening and lightening, and recurrent thrush.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
273658
Start Date
March 31, 2016
Effective Date
March 31, 2016
Manufacturer
Country
South Korea
Address
9F 25 Deokcheon-ro 152beon-gil Manan-gu, Anyang-si, Gyeonggi-do, 14084