Corneal

Main information

  • Trade name:
  • Corneal topography system
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Corneal topography system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219343
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219343

IQ Medical - Corneal topography system

ARTG entry for

Medical Device Included Class IIa

Sponsor

IQ Medical

Postal Address

2 / 86 Mary Street,UNLEY, SA, 5061

Australia

ARTG Start Date

16/01/2014

Product category

Medical Device Class IIa

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

I-Optics BV

Mauritskade

Den Haag, , 35 2514 HD

Netherlands

Products

1. Corneal topography system

Product Type

Single Device Product

Effective date

16/01/2014

GMDN

18038 Corneal topography system

Intended purpose

An assembly of ophthalmic devices consisting of a line-powered diode laser that uses a solid as a

substrate, a videokeratoscope for imaging and application software for installation in an included computer

workstation, for image processing and analysis. This device is used to evaluate the curvature of the

cornea, by measuring the curvature and concentricity of the corneal surface, in preparation and planning

of Ophthalmic surgical procedures.

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 07:53:06 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