Australia TGA ARTG record

Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction

Australia TGA ARTG Registered Device · Jonathan Kew Private Assists · Deka M E L A Srl · Class IIb · Started March 18, 2022

Good Name: Jonathan Kew Private Assists - Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction

Device classification

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

Registration information

Start Date: March 18, 2022
Effective Date: March 18, 2022

Sponsor

Name: Jonathan Kew Private Assists

Manufacturer

Name: Deka M E L A Srl
Country: Italy
Address: Via Baldanzese 17, Calenzano Firenze, FI, 50041

Intended purpose

The Onda system is a medical device intended for deep heating of the adipose tissue for the treatment of lipodystrophy, edematous fibrosclerotic panniculopathy and for body contouring in dermatological, plastic surgery and aesthetic medicine environments.

About this record

Access comprehensive regulatory information for Onda - Skin Contouring system, Multifunction - Skin contouring system, multifunction in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Jonathan Kew Private Assists, manufactured by Deka M E L A Srl in Italy. The device registration started on March 18, 2022.

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.