Multi-modality

Main information

  • Trade name:
  • Multi-modality skin surface treatment system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Multi-modality skin surface treatment system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218763
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218763

Device Consulting Pty Ltd - Multi-modality skin surface treatment system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Device Consulting Pty Ltd

Postal Address

Unit 16 / 24 Brand Drive,THOMASTOWN, VIC, 3074

Australia

ARTG Start Date

21/12/2013

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

Asclepion Laser Technologies GmbH

Brusseler Strasse 10

Jena, , 07747

Germany

Products

1. Multi-modality skin surface treatment system

Product Type

Single Device Product

Effective date

21/12/2013

GMDN

45220 Multi-modality skin surface treatment system

Intended purpose

For removal of unwanted hair/hair removal. Also for non-invasive vascular treatments/treatment of

vascular lesions including leg veins, hemangiomas and other ectatic vessels.

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 09:24:33 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