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Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - ARTG 351591

Access comprehensive regulatory information for Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - 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 351591 and sponsored by Cutera Australia Pty Ltd, manufactured by Cutera Inc in United States of America. The device registration started on December 10, 2020.

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 351591
Class IIb
Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
ARTG ID: 351591
Good Name: Cutera Australia Pty Ltd - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
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Intended Purpose

Intended for use in medical and cosmetic procedures in the specialties of dermatology, plastic surgery, and aesthetic medicine. Specific indications: -Treatment of benign vascular lesions including, but not limited to, telangiectasia, angiomas, port wine stains, diffuse redness, poikiloderma of civatte, rosacea, leg veins, periocular veins, venous lakes, and hemangiomas -Treatment of benign pigmented lesions including, but not limited to, senile and solar lentigines, dermatosis papulose nigra, ephelides, dyschromia, and nevi -Treatment of benign cutaneous lesions including, but not limited to, wrinkles, verrucae, seborrheic keratoses, acne scars, skin tags, erythematous scars, bruising, and mild to moderate acne vulgaris -Hair removal -Treatment of pseudofolliculitis barbae

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
351591
Start Date
December 10, 2020
Effective Date
December 10, 2020
Manufacturer
Country
United States of America
Address
3240 Bayshore Boulevard, Brisbane, California, 94005