First Fractional Laser FDA Cleared For Striae
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Palomar Medical Technologies, Inc. is pleased to announce that the Lux1540™ Fractional non-ablative laser handpiece has received the first clearance by the United States Food and Drug Administration (FDA) for the treatment of striae (stretch marks) using a fractional laser. This new clearance will allow aesthetic practitioners to treat the millions of women worldwide who have unwanted stretch marks.
Ongoing clinical studies have shown that subjects treated with the Lux1540 achieved an average improvement of between 51% and 75% in the appearance of their striae, based upon a blinded review of photographs comparing the pre-treatment appearance of striae versus the results three months post-treatment.
Francesca de Angelis, MD, a leading plastic surgeon from Naples, Italy who has led the research effort, noted, "Through our ongoing clinical study, and with thousands of satisfied patients treated throughout Italy, we have found that the Lux1540 is the first laser treatment for stretch marks that truly works."
"Our experience with the Palomar Lux1540 is consistent with the results seen in Europe," noted Vic Narurkar, MD, a dermatologist in San Francisco, CA and past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "For the right patient, the Lux1540 provides a laser treatment option for stretch marks that offers significant improvement. The non-ablative fractional laser allows for comfortable treatments with little to no impact on the patient's daily activities."
Carolyn Chang, MD, Vice-Chair of Plastic Surgery at California Medical Center in San Francisco, believes fractional laser treatment for stretch marks will be a highly-requested procedure in her practice. "After pregnancy, women are always looking to eliminate their stretch marks. The Palomar laser can play a key role in the 'mommy makeover' so many new mothers are asking for."
Robert Weiss, MD, director of the Maryland Laser, Skin, and Vein Institute and immediate past president of the American Society for Dermatologic Surgery, added, "I have tested many of the available fractional lasers, and Palomar's Lux1540 looks to fulfill a long sought after need for a comfortable treatment with very high patient satisfaction for stretch marks."
This new clearance expands the broad range of treatments offered by the Lux1540, which may be used to treat surgical scars, acne scars, and melasma, as well as offer non-ablative skin resurfacing. In support of this new clearance, Palomar in conjunction with Body1.com has released a consumer education site, Stretchmarks1.com, to help consumers understand more about treatment options and locate providers of Palomar's Lux1540 technology for stretch marks.
The Lux1540 Fractional non-ablative laser handpiece is available for use with Palomar's flagship StarLux® 500 laser and pulsed light platform. The StarLux 500 allows practitioners to attach a variety of application-specific handpieces to one base unit that easily expands as their practice grows.
About Palomar Medical Technologies, Inc: Palomar is a leading researcher and developer of light-based systems for cosmetic treatments. Palomar pioneered the optical hair removal field, when, in 1997, it introduced the first high-powered laser hair removal system. Since then, many of the major advances in light-based hair removal have been based on Palomar technology. In December 2006, Palomar became the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home-use, light-based hair removal device. In June 2009, Palomar became the first company to receive a 510(k) OTC clearance from the FDA for a new, patented, home-use, laser device for the treatment of periorbital wrinkles. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription. There are now millions of light-based cosmetic procedures performed around the world every year in physician offices, clinics, spas and salons. Palomar is testing many new and exciting applications to further advance the hair removal market and other cosmetic applications. Palomar is focused on developing proprietary light-based technology for introduction to the mass markets.
Source: Palomar Medical Technologies, Inc
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