European society proposes OTC device guidelines aimed at consumer safety

August 1, 2011

Rapid market growth of light-based home-use devices for cosmetic purposes coupled with a lack of standardization within and regulation of the industry has prompted the European Society for Laser Dermatology (ESLD) to propose safety guidelines for home-use technology.

Key Points

Grapevine, Texas - Rapid market growth of light-based home-use devices for cosmetic purposes coupled with a lack of standardization within and regulation of the industry has prompted the European Society for Laser Dermatology (ESLD) to propose safety guidelines for home-use technology.

Dr. Haedersdal is associate professor of dermatology, Bispebjerg Hospital, Faculty of Health Sciences, University of Copenhagen, Denmark. She spoke on behalf of her colleagues who compose a six-member ESLD panel organized to develop guidelines for safe use of at-home light and laser devices.

Dr. Haedersdal defines a light-based home-use device as a system intended for cosmetic or beauty self-treatment, excluding any medical product to be used for disease diagnosis or treatment. She says since the first of these devices was introduced about five years ago, the number of platforms for sale has rapidly proliferated, and total sales are also rising briskly.

In April, at the time of her ASLMS presentation, there were 10 light-based home-use devices on the European market for hair removal, including eight intense pulsed light (IPL) devices and two laser systems, along with one laser system approved for skin rejuvenation.

Inconsistent information provided by manufacturers of home-use light and laser devices on technical parameters that influence treatment safety represents one deficiency that the guidelines hope to influence, Dr. Haedersdal says. Fluence, pulse duration and wavelength are all factors that can affect the risk of complications with these systems. In their review of product labeling, however, the ESLD panel found that not all manufacturers provided data on these parameters.

"Not even half of the devices on the market have full technical information on output specifications," she says.

The guidelines also recommend that manufacturers test their devices for their potential to cause ocular damage and burns to the skin.

"It is known that wavelengths in the visible and infrared spectrums can cause various types of ocular injury. Visible wavelengths can damage the retina, leading to blind spots, and also cause damage to the pigmented iris that can result in glaucoma. Shorter and longer wavelengths can also cause corneal damage, both by direct exposure and indirectly to persons in the vicinity of the device," Dr. Haedersdal says.

"Since the mechanism of action of home-based devices for their cosmetic indications is based on inducing a thermal reaction, there is also a risk of adverse effects to the skin, including erythema but also crusting, pigmentary changes and leukotrichia," she says.