Electrosurgical

Main information

  • Trade name:
  • Electrosurgical system handpiece, foot-controlled, single-use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electrosurgical system handpiece, foot-controlled, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216972
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216972

Lumos Medical Pty Ltd - Electrosurgical system handpiece, foot-controlled, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

Lumos Medical Pty Ltd

Postal Address

23 Tomanbil Terrace,ASHMORE, QLD, 4214

Australia

ARTG Start Date

6/11/2013

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

NeoMedix Corp

15042 Parkway Loop Suite A

Tustin, CA, 92780

United States Of America

Products

1. Electrosurgical system handpiece, foot-controlled, single-use

Product Type

Procedure Pack

Effective date

6/11/2013

GMDN

44678 Electrosurgical system handpiece, foot-controlled, single-use

Intended purpose

Procedure pack:

The Trabectome® Handpiece is intended to be used in electrosurgical applications in soft tissue in general

and in

ophthalmic surgery where low impedance or wet field conditions exist. In ophthalmic surgery, the

Handpiece is

designed to surgically remove a strip of the Trabecular Meshwork for surgical management of infantile and

adult

glaucoma.

The handpiece is packaged with, and used when attached to, a single use ophthalmic irrigation/aspiration

cannula, and a surgical irrigation tubing set.

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 03:44:42 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