Main information

  • Trade name:
  • Intense pulsed light skin surface treatment system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Intense pulsed light skin surface treatment system
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222493
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Advanced Cosmeceuticals - Intense pulsed light skin surface treatment system

ARTG entry for

Medical Device Included Class IIb


Advanced Cosmeceuticals

Postal Address

38 Automotive Drive,WANGARA, WA, 6065


ARTG Start Date


Product category

Medical Device Class IIb



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.




Lutronic Corporation

Lutronic Center 219 Sowon-ro Deogyang-gu

Goyang-si, Gyeonggi-do,

Korea - Republic of


1. Intense pulsed light skin surface treatment system

Product Type

Single Device Product

Effective date



58935 Intense pulsed light skin surface treatment system

Intended purpose

A device intended to produce strong, controlled flashes of filtered light to cause ablation of skin cells to

treat a variety of skin/pigmentation conditions. The device is typically used for the treatment of acne,

rosacea, telangiectasia, pigmented lesions, vascular lesions, melasma, and hair removal.

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 09.11.2017 at 09:22:27 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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