Ellex

Main information

  • Trade name:
  • Ellex Lasers - Laser, diode pumped solid-state
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ellex Lasers - Laser, diode pumped solid-state
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221984
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221984

Ellex Medical Pty Ltd - Ellex Lasers - Laser, diode pumped solid-state

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Ellex Medical Pty Ltd

Postal Address

82 Gilbert Street,ADELAIDE, SA, 5000

Australia

ARTG Start Date

3/04/2014

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

Ellex Medical Pty Ltd

82 Gilbert Steet

ADELAIDE, SA, 5000

Australia

Products

1. Ellex Lasers - Laser, diode pumped solid-state

Product Type

Medical device system

Effective date

3/04/2014

GMDN

44731 Laser, diode pumped solid-state

Intended purpose

Diode pumped solid-state (DPSS) lasers with integrated slit lamp for the treatment of ocular pathology

within the human eye, such as photocoagulation for the treatment of retinal diseases.

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 09.11.2017 at 11:02:11 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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