Australia TGA ARTG record

1726 nm Laser System - Dermatological Nd:YAG laser system

Australia TGA ARTG Registered Device · Cutera Australia Pty Ltd · Cutera Inc · Class IIb · Started June 21, 2021

Good Name: Cutera Australia Pty Ltd - 1726 nm Laser System - Dermatological Nd:YAG laser system

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: June 21, 2021
Effective Date: June 21, 2021

Sponsor

Name: Cutera Australia Pty Ltd

Manufacturer

Name: Cutera Inc
Country: United States of America
Address: 3240 Bayshore Boulevard, Brisbane, California, 94005

Intended purpose

Intended for use in medical and cosmetic procedures in the specialties of dermatology, plastic surgery, and aesthetic medicine. Specific indications: -Treatment of mild to severe inflammatory acne (acne vulgaris) -Treatment of acne scars -Treatment of sebaceous hyperplasia

About this record

Access comprehensive regulatory information for 1726 nm Laser System - Dermatological 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 Cutera Australia Pty Ltd, manufactured by Cutera Inc in United States of America. The device registration started on June 21, 2021.

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.