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diode suppler Oclaro, however Summer does not comment on how Pantec will ensure this technology will be made affordable for home use. As with other devices on the market, Pantec aims to get FDA approval for its P.L.E.A.S.E Private device. ‘We are confident that we will get FDA approval,’ says Summer. ‘By having the P.L.E.A.S.E. Professional on the market means the reliability and safety of the device will be shown. Furthermore, several other home-use devices will be on the market by then and the FDA will have more practical experience with home-use devices.’
Meeting regulation requirements is often one of the biggest hurdles a new product has to overcome. The at-home light-based device market is so new and evolving so quickly that regulations have not yet caught up. In the US, the FDA regulates the sale of consumer-use light-based products and treats them as medical devices requiring pre-marketing clearance before they can be offered for sale. In Europe however, the equivalent organisations,
such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) does not regulate such consumer devices used for hair removal or wrinkle treatments as they consider these cosmetic applications and outside of their scope of responsibility. The only requirement is that such products meet European Directives and carry the CE mark.
The at-home light-based device
market is so new... that regulations have not yet caught up
Currently, there are no British or international
standard specifically covering home-use light- based devices and it is unlikely that any such standard will be available before the end of 2013. The consumer market is very fragile – one accident or mistake and the whole market’s reputation could be ruined. To protect this fragile market, large companies are taking steps to ensure consumers use their products safely, despite there being no legal requirement for them to do so. For example, in the UK the RéAura
is sold through the online cosmetics shopping site Space NK. Unlike most products on the site, consumers cannot simply buy the product online – they must phone Space NK where a skin analysis is then undertaken as part of the registration process for online support. ‘Companies such as Philips don’t want smaller companies coming onto the market and ruining the reputation of the technology,’ says Godfrey Town, an UK-based independent laser protection advisor. ‘That is why they are keen to develop standards and tighter regulation of the market.’ Town is part of an international task force of scientists and clinicians from the European Society for Laser Dermatology which is calling for tighter guidelines on the safety of light-based home-use devices. The initiative has the backing of all the large players in this industry. ‘Europe is tightening its regulations covering
professional providers of light-based therapy but because the at-home devices are not classed as medical devices, these tighter regulations will not impact the consumer market,’ says Town. ‘There is an urgent need for specific regulation of light- based devices for use in the home.’ l
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www.electrooptics.com FEBRUARY 2012 l ELECTRO OPTICS 15
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