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Ultrasonic skin contouring system applicator

Access comprehensive regulatory information for Ultrasonic skin contouring system applicator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by LC & Partners Pty Ltd, manufactured by Sofwave Medical Ltd in Israel. The device registration started on October 25, 2023.

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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Class IIa
Class IIa
Ultrasonic skin contouring system applicator
Australia TGA ARTG Registered Device
Good Name: LC & Partners Pty Ltd - Ultrasonic skin contouring system applicator
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Intended Purpose

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite. The Sofwave Applicator is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 25, 2023
Effective Date
October 25, 2023
Manufacturer
Country
Israel
Address
1 Ha-Otsma St 4th floor, Yokneam, IlIit, 2069200