First FDA 510(k) approval for home-use wrinkle-treatment device goes to Palomar

JUNE 9, 2009--Palomar Medical Technologies (Burlington, MA) has become the first company to win a 510k over-the-counter (OTC) clearance from the U.S. Food and Drug Administration (FDA) for a home-use laser skin treatment device for the reduction of periorbital wrinkles (a.k.a. eye wrinkles or crow's feet). The FDA clearance allows the cosmetic laser device, which provides an alternative to Botox treatments, to be marketed and sold directly to consumers without a prescription.

Palomar developed the patented device and completed it with Johnson and Johnson Consumer Companies under an agreement the partners made to develop light-based anti-aging devices. Designed specifically for use in the home and based on years of research and clinical testing, the device represents a major breakthrough in the aesthetic device industry, according to Palomar.

"This FDA clearance for a laser to treat wrinkles in the home opens up a tremendous opportunity to tap into the multi-billion dollar consumer skin care market with our patented technology," said Palomar CEO Joseph P. Caruso. "The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors' office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost. This latest clearance further validates Palomar's investment in research and development in the field of light-based anti-aging treatments and adds to the list of distinctions for Palomar as a technology leader in our industry."

Caruso continued, "Years ago, we believed that light-based anti-aging applications could be brought to the home. We invested significant resources in research, development, clinical testing, and patent protection to make this a reality and ensure that Palomar would be the leader with this innovative technology. We envision a strong market for this OTC device and an increase in consumer awareness to help drive growth in our professional business."

For more information see Palomar's website.

Posted by Barbara G. Goode, barbarag@pennwell.com, for BioOptics World.

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