Australia TGA ARTG recordSkin contouring system, radio-frequency
Australia TGA ARTG Registered Device · Cutera Australia Pty Ltd · Cutera Inc · Class IIb · Started January 23, 2013
Good Name: Cutera Australia Pty Ltd - Skin contouring system, radio-frequency
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- January 23, 2013
- Effective Date
- January 23, 2013
- Name
- Cutera Inc
- Country
- United States of America
- Address
- 3240 Bayshore Boulevard, Brisbane, California, 94005
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.
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.