Skin contouring system, radio-frequency

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Viso Aesthetics Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322091

Public Summary

Summary for ARTG Entry:

322091

Viso Aesthetics Pty Ltd - Skin contouring system, radio-frequency

ARTG entry for

Medical Device Included Class 1

Sponsor

Viso Aesthetics Pty Ltd

Postal Address

Unit 6,6 Mortimer Lewis Drive,Huntleys Cove, NSW, 2111

Australia

ARTG Start Date

21/08/2019

Product category

Medical Device Class 1

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

Quanteq Co Ltd

F548H 5F #45 Jojeong daero

Hanam-si, Gyeonggi-do,

Korea - Republic of

Products

1. Skin contouring system, radio-frequency

Product Type

Single Device Product

Effective date

21/08/2019

GMDN

45219 Skin contouring system, radio-frequency

Intended purpose

This device transmits multi wavelength high frequency energy specifically to interact with skin cells. This

results in skin tightening, improvements in texture, firmness and elasticity.

Specific Conditions

© 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 02.11.2019 at 06:23:49 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

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