Earlier this month, Palomar, a leading researcher and developer of light-based systems for cosmetic treatments, became the first company to receive 510(k) over-the-counter clearance from the U.S. Food and Drug Administration (FDA) for its new patented laser device that can be used in the home for the treatment of periorbital wrinkles. FDA clearance allows Palomar to market and sell the device directly to consumers without a prescription.
The device, which was developed by Palomar and completed together with Johnson and Johnson Consumer Companies, Inc., is considered a major breakthrough in the aesthetic device industry. “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,” notes Palomar Chief Executive Officer Joseph P. Caruso.
In 1997, Palomar pioneered the optical hair removal market, introducing the industry’s first high-powered laser hair removal system. In late 2006, it became the first company to receive 510(k) over-the-counter clearance from the FDA for a home use light-based hair removal device. Says Caruso: “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. We envision a strong market for the home use wrinkle removal laser device and an increase in consumer awareness to help drive growth of our professional business.”
News Release: FDA approves Palomar’s anti-wrinkle device www.plasticsurgerypractice.com June 5, 2009
Press Release: Palomar receives FDA over-the-counter clearance for a home use wrinkle removal laser device www.phx.corporate-ir.net June 5, 2009
