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Derm Devices

By: Leslie Benson
Posted: August 21, 2008, from the September 2008 issue of Skin Inc. magazine.
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It’s no wonder, says Fields, that hair removal and hair growth laser treatments are rising in popularity in the device category. “They can be costly,” says Fields, “but there are no sterile parts, so you can give them to others to use. Some of these devices can be used by the whole family.”

Regulations

Unlike the natural and organic personal care market, which has skin care industry professionals debating standards of certification, not all cosmetic device manufacturers have pursued government-regulated approval or clearance. However, in the case of products considered to not pose significant risk to the general public by the U.S. Food and Drug Administration (FDA), some companies believe such clearance is unnecessary.

By FDA standards, some of Bio-Therapeutic’s devices are considered Class I, according to Suzuki, meaning the devices are only required “to be registered with the FDA and manufactured under the Good Manufacturing Practices.” Carol Cole Company’s device uses microcurrents to tone and lift skin; however, as a Class II device, it falls under more rigorous FDA guidelines, such as labeling requirements, stringent performance standards and post-market surveillance. These guidelines extend even further with Class III devices. But Hawkins insists maintaining such high regulatory controls in the design and manufacturing of home-use devices affords consumers a higher level of protection.

Fields concurs, suggesting device manufacturers offer a 30–60 day money-back guarantee to set consumers’ minds at ease. “The customer today is smart and doesn’t want to pay a lot of money for hope in a jar. Everyone wants a fast fix, but there’s a price limit,” Fields says. Her company, Rodan + Fields, currently has researchers scientifically testing blue light therapies for possible use in a future home skin care device, and Fields’ biggest concerns are the devices currently in the market that don’t work as intended. “That annoys us to no end,” she says.

Device expectations

The key seems to lie in convenience, where at-home devices are on top of the heap, but there are still skeptics, such as Rick Krupnick, CEO of Light BioScience LLC, a manufacturer of professional-grade medical devices. “People want to know the product they’re getting is safe, effective and fast,” he says.