Radio-frequency

Main information

  • Trade name:
  • Radio-frequency skin surface treatment system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Radio-frequency skin surface treatment system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222145
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222145

Advanced Cosmeceuticals - Radio-frequency skin surface treatment system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Advanced Cosmeceuticals

Postal Address

38 Automotive Drive,WANGARA, WA, 6065

Australia

ARTG Start Date

8/04/2014

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

Lutronic Corporation

Lutronic Center 219 Sowon-ro Deogyang-gu

Goyang-si, Gyeonggi-do,

Korea - Republic of

Products

1. Radio-frequency skin surface treatment system

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

58454 Radio-frequency skin surface treatment system

Intended purpose

The INFINI device is intended to deliver radio frequency energy to heat the skin surface for ablation,

coagulation, and for skin resurfacing. The device is typically used for the treatment of scar revision.

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 10:38:10 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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