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Derm Devices: Taking Antiaging In Hand
By: Leslie Benson
Posted: April 2, 2008, from the April 2008 issue of GCI Magazine.
page 4 of 5By FDA standards, Bio-Therapeutic’s bt-Gear devices are considered Class 1, according to Suzuki, meaning the devices are only required “to be registered with the FDA and manufactured under the Good Manufacturing Practices.” Similar to bt-Gear, the NuFace uses microcurrents to tone and “lift skin.” However, as a Class II device, NuFace falls under more rigorous FDA guidelines (such as labeling requirements, stringent performance standards and post-market surveillance). These guidelines extend even further to 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. Rodan + Fields currently has researchers scientifically testing blue light therapies for possible use in a future home skin care device. Her biggest concerns are the devices in the market currently that don’t work as intended. “That annoys us to no end!” she says.
The key seems to lie in convenience, and 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,” says Krupnick, whose GentleWaves LED Photomodulation System has recently received 510(K) over-the-counter clearance from the FDA.
Although he says women tend to be more compliant when it comes to following cosmetic treatment protocol, Krupnick believes men are beginning to show interest in the market category, as well. According to Priti Odedra, vice president of business development of the Revenir and Charme Skincare Systems, men are learning more about what they can do at home to reverse the signs of aging. “We’re finding men are more open to looking at a device type process versus a gel or lotion,” she says. “Just the fact that it’s a gadget has helped us.”