Extract of the Records

STUDY HIGHLIGHTS DANGERS OF NOVELTY LASER PRODUCTS WHEN MISUSED

A recent study raises concerns over potential damage to vision from beams emitted by novelty laser products.

Available for the public here.

HUD RELATED INFORMATION PRESENTED IN PHOENIX 2014

Content:

- Posters of Interest
- Abstracts of Interest

Posters and abstracts are only available for members (Member Area) of the HUD Working Group.

HUD SYMPOSIUM 2013 IN CANNES

Content:

- Home use devices: market size, dynamics, trends and review of recent innovations.
- Advancing capabilities of home-use fractional laser: beyond periorbital wrinkles.
- Efficacy & Safety of home-use devices for hair removal and skin rejuvenation.
- Safety in Home Use Appliances: Engineering Design and Interlocks.
- Making Contact - The Class 1C Debate What are we still struggling with?
- Is it possible to make hand delivered medical/cosmetic laser equipment inherently safe?
- Clinical Trial Results Update Using Fractional Home-Use Devices [10 minute VIDEO].
- Clarisonic’s Home-Use Devices
- Home Use of Intense Therapy Ultrasound (ITU): principals and clinical applications.
- International Progress in Standards and Regulation for Light-Based Home-Use Devices
- Home-Use IPL and Laser Hair Removal Devices: End-to-End Human Safety
- Comparative Results of Home-Use Device Clinical Trials.
- What are the implications of rewording of the GPSD? What options might exist for home-use directed energy devices if they were to be reclassified as medical devices?
- Home Use Efficacy and Safety Study for Mild to Moderate Acne.
- Safety, Efficacy and Acceptability Testing of Home Use Devices with a CRO.
- Is light the new drug for OTC applications?

Videos, Posters and abstracts are only available for members (Member Area) of the HUD Working Group.

HOME USE DEVICE WORKING GROUP - PRESENTATIONS

Paris 31st January - 03rd February 2013

Date: Saturday, 02nd February 2013

Session 63 - Room 6
The power of  home devices
Chairs: Klaus Fritz, Moshe Lapidoth

Program:
Rejuvenation with light-based home devices: a new option?, Godfrey Town
Home-treatments with fractional lasers, Peter Bjerring


The whole presentations are only for members (Member Area) of the HUD Working Group available.

HUD Webinar - Verona, 08.06.2012

Content:

- Review of Initial Working Group Meeting held at Gaylord Palms Resort 20th April 2012
- The 'Purpose' of the Working Group
- Proposed ‘Work Packages’ to be addressed by sub-groups
- The current and projected standards & regulatory environment
- Communications about efficacy and safety of home use, light-based devices
- Marketing the work of the HUD Working Group
- Financing the Working Group
- Future Events & Potential HUD Meeting Dates

 For the whole Video, please contact us.

INTERNATIONAL PROGRESS IN STANDARDS AND REGULATION FOR LIGHT BASED HOME USE DEVICES

Godfrey Town1, Wolfram Gorisch2

1 University of Wales, Global Academy, Swansea Metropolitan University, Swansea, SA1 6ED, UK.
2 Laser Protection Consultant, 81929 Munich, Germany

Abstract:

The recent development of light-based laser and intense light devices for consumer use with or without physician direction has raised new challenges in safety standards and regulatory requirements for these
appliances.

Home-use laser products have emission levels from 'embedded' lasers that would ordinarily result in their having laser hazard classifications of 3B or 4, but because of design features and interlocks, cannot emit radiation which is hazardous to the eye when the product is in contact with the skin.

The complete Paper is only for members (Member Area) of the HUD Working Group available.

HOW ARE MEDICAL DEVICES REGULATED IN THE EUROPEAN UNION?

Elaine French-Mowat1, Joanne Burnett2

1 Guildford Medical Device Evaluation Centre (GMEC), The Royal Surrey County Hospital, Egerton Road, Guildford, Surrey GU2 7XX
2 NICE – MTEP, Level 1A City Tower Piccadilly Plaza, Manchester M1 4BD, UK

Summary:

Medical devices cannot be placed on the European market without conforming to the strict safety requirements of the European Union; one of these requirements is the affixation of the CE conformity mark.

This article is an overview of the CE marking process only; it is not a document that should be referred to on its own. All manufacturers wishing to gain a CEmark should refer to the official documents.

 

Posters and abstracts are only available for members (Member Area) of the HUD Working Group.

TECHNICAL COMMITTEE NO. 61: SAFETY OF HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES

TC61/WG30 proposal for new IEC 60335, Part 2-xx: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources

This is the latest "PRIVATE CIRCULATION" draft of the proposed new home-use device standard issued by the IEC working group TC61 WG30. This draft is the culmination of several WG30 Working Group meetings with expert input from at least two other IEC Working Groups. This is a "clean" document for National Committee (this copy has been issued to the UK TC61 members for review) and therefore does not any of the changes from the previous Committee Draft document.

Any further comment from manufacturers or individual experts should be directed through their local IEC TC61 National Committee who will also be considering this draft.

The whole content is only for members (Member Area) of the HUD Working Group available.