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

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

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

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