Surgical instrument fibreoptic light

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

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Available from:
KT Medical Pty Ltd
Class IIa
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


KT Medical Pty Ltd - Surgical instrument fibreoptic light

ARTG entry for

Medical Device Included Class IIa


KT Medical Pty Ltd

Postal Address

262 Albert Road,SOUTH MELBOURNE, VIC, 3205


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Lumitex Medical Devices Inc

8443 Dow Circle

Strongsville, OH, 44136

United States Of America


1. Surgical instrument fibreoptic light

Product Type

Single Device Product

Effective date



48036 Surgical instrument fibreoptic light

Intended purpose

A sterile, single use device, intended to conduct cold light from a connected fibreoptic light cable and light

source into a surgical wound for illumination during a surgical intervention.

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

Public Summary

Page 1 of

Produced at 03.11.2017 at 04:11:48 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.

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