Electrosurgical

Main information

  • Trade name:
  • Electrosurgical system generator, general-purpose
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electrosurgical system generator, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221316
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221316

Device Consulting Pty Ltd - Electrosurgical system generator, general-purpose

ARTG entry for

Medical Device Included Class 1

Sponsor

Device Consulting Pty Ltd

Postal Address

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

Australia

ARTG Start Date

15/03/2014

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

Miramar Labs Inc

2790 Walsh Avenue

Santa Clara, CA, 95051

United States Of America

Products

1. Electrosurgical system generator, general-purpose

Product Type

Single Device Product

Effective date

15/03/2014

GMDN

11490 Electrosurgical system generator, general-purpose

Intended purpose

Accessory items to the miraDry system used for the treatment of primary axillary hyperhidrosis.

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 01:26:59 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