Ultrasonic

Main information

  • Trade name:
  • Ultrasonic body-contouring system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultrasonic body-contouring system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218571
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218571

Syneron Candela Corporation Australia Pty Ltd - Ultrasonic body-contouring system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Syneron Candela Corporation Australia Pty Ltd

Postal Address

PO Box 252,PROSPECT, SA, 5082

Australia

ARTG Start Date

14/12/2013

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Syneron Medical Ltd

Industrial Zone Tavor Building

Yokneam Illit, , 20692

Israel

Products

1. Ultrasonic body-contouring system

Product Type

Single Device Product

Effective date

14/12/2013

GMDN

45591 Ultrasonic body-contouring system

Intended purpose

for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to

grow (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The use of

this system may serve as a noninvasive outpatient procedure alternative to liposuction.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:02:25 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information