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Skin contouring system, radio-frequency

Access comprehensive regulatory information for Skin contouring system, radio-frequency 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 January 23, 2013.

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
Class IIb
Skin contouring system, radio-frequency
Australia TGA ARTG Registered Device
Good Name: Cutera Australia Pty Ltd - Skin contouring system, radio-frequency
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Intended Purpose

An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within body tissues to temporarily minimize the manifestation of cellulite, loose or wrinkled skin through a process of fat removal, skin regrowth and tightening, and the temporary relief of pain. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed in a controlled manner to produce the desired therapeutic effect whilst cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 23, 2013
Effective Date
January 23, 2013
Manufacturer
Country
United States of America
Address
3240 Bayshore Boulevard, Brisbane, California, 94005