Intense

Main information

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

Documents

Localization

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

Other information

Status

  • 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:

222493

Advanced Cosmeceuticals - Intense pulsed light 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

15/04/2014

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. Intense pulsed light skin surface treatment system

Product Type

Single Device Product

Effective date

15/04/2014

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

There are no news related to this product.