Cosmetic

Main information

  • Trade name:
  • Cosmetic Phototherapy system, professional - Cosmetic phototherapy system, professional
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cosmetic Phototherapy system, professional - Cosmetic phototherapy system, professional
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221886
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221886

EFB Australia Pty Ltd - Cosmetic Phototherapy system, professional - Cosmetic phototherapy system,

professional

ARTG entry for

Medical Device Included Class IIb

Sponsor

EFB Australia Pty Ltd

Postal Address

25 Burton Street,GLEBE, NSW, 2037

Australia

ARTG Start Date

1/04/2014

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

Eurofeedback SAS

Zl de la Petite Montagne Sud 3 rue de L'Aubrac

, Evry, 91017

France

Products

1. Cosmetic Phototherapy system, professional - Cosmetic phototherapy system, professional

Product Type

Medical device system

Effective date

1/04/2014

GMDN

47705 Cosmetic phototherapy system, professional

Intended purpose

A Polychromatic Pulsed Lamp designed to treat benign skin damage or minor anomalies exclusively on

the surface of human skin. The skin damage concerned is of the following types: vascular; port wines

stains, rosacea, or telangiectasia; pigmentary: Lentigines, Actinic Keratosis, Follicular Keratosis; Acne:

hormonal acne hyperkeratosis of the sebaceous gland; and, hair removal treatment: hirsutism, of

hypertrichosis or for the esthetical purposes.

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 11:24:09 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

12-3-2019

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

Out of an abundance of caution, today Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.

FDA - U.S. Food and Drug Administration

12-3-2019

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA - U.S. Food and Drug Administration

5-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

FDA - U.S. Food and Drug Administration

12-12-2018

December 4, 2018: Des Moines Residents Sentenced for Felony Federal Food, Drug, and Cosmetic Act Offense

December 4, 2018: Des Moines Residents Sentenced for Felony Federal Food, Drug, and Cosmetic Act Offense

December 4, 2018: Des Moines Residents Sentenced for Felony Federal Food, Drug, and Cosmetic Act Offense

FDA - U.S. Food and Drug Administration

15-11-2018

Vanpak Limited recalls various Cosmetic products in pressurised containers.

Vanpak Limited recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

15-11-2018

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

MPS Canada Corporation recalls various Cosmetic products in pressurised containers.

The recalled products do not have mandatory hazard labelling as required by the Cosmetics Regulations under the Food and Drugs Act. Improper labelling could result in misuse of the product and lead to serious injury.

Health Canada

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

30-8-2018

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (...

FDA - U.S. Food and Drug Administration

1-6-2018

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

The recalled products may be contaminated with the bacteria Burkolderia cepacia. Burkolderia cepacia can pose a risk of infections to consumers, especially those with weakened immune systems. Contamination of the bacteria has only been confirmed for the Remedy Essentials Cleanser No Rinse Foam that was includedin the previous recall.

Health Canada

19-5-2018

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Health Canada is advising Canadians that it has seized an unauthorized “Botox” product and other unauthorized health products from Arshia Hair Salon and Spa (6062A Yonge Street) in Toronto, ON, because they may pose serious health risks. These products may have been administered as injectable treatments for cosmetic purposes.

Health Canada

5-3-2010

What's New in Cosmetics

What's New in Cosmetics

Recent updates to FDA cosmetics content, including major changes to existing documents and new documents added.

FDA - U.S. Food and Drug Administration

29-11-2018

Company will pay over $25,000 in fines for alleged importation of unapproved therapeutic goods

Company will pay over $25,000 in fines for alleged importation of unapproved therapeutic goods

Operation Antlia targeted the illegal use of therapeutic goods in the cosmetics industry

Therapeutic Goods Administration - Australia

20-11-2018

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more:  https://go.usa.gov/xPAzk  #MedicalDevicepic.twitter.com/pv0k2yaNfj

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevicepic.twitter.com/pv0k2yaNfj

. @US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevice pic.twitter.com/pv0k2yaNfj

FDA - U.S. Food and Drug Administration

30-7-2018

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures  http://go.usa.gov/xUdgB  #MedicalDevice

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures http://go.usa.gov/xUdgB  #MedicalDevice

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures http://go.usa.gov/xUdgB  #MedicalDevice

FDA - U.S. Food and Drug Administration