Lutronic's Spectra Laser Receives FDA Clearance for the Treatment of Melasma
Lutronic, Inc., announced today that the U.S. Food and Drug Administration has granted regulatory clearance for the treatment of melasma utilizing their acclaimed SPECTRA Q-switched laser. As a global technology company, Lutronic develops, manufactures and commercializes lasers and alternative therapeutic devices for aesthetic and medical applications. “We are most pleased because this clearance will encourage physicians to apply Spectra’s unique technical advantages in the treatment of this challenging condition,” said Jhung Vojir, Ph.D, and CEO of U.S. operations. Melasma is a disturbing skin disorder that presents as dark spots and patches on facial skin and most commonly occurs in people of Asian, Latin, African or Native American backgrounds. These individuals, because their skin contains high levels of melanin, are more susceptible to functional issues with skin cells that produce and contain melanin pigment. That said, melasma can afflict any ethnic group and even people with fair skin may suffer from melasma.
Clinical studies have been performed to test the efficacy of Spectra in the treatment of melasma in the Asian population. A controlled split face study, conducted in Korea, showed that the application of the 1064 Qswitched laser, at low fluence and short pulse widths, produced a statistically significant reduction in the appearance of melasma. In the United States, dermatologists have struggled to find the right mix of therapies to control the condition. Dr. Jeffery A. Rapaport, M.D., who has used Spectra in his clinic for years was glad the FDA recognized the challenge of treating melasma. “Melasma has been exceedingly difficult to manage. We now have a proven treatment for all skin types. “
Immediately, Lutronic’s clinical group will proceed to train current Spectra owners on the optimal treatment protocols that will ensure a higher success rate in the clearance of melasma going forward.
Headquartered in Seoul, Korea, Lutronic Corporation formed in 1997, is a publicly listed global company (KOSDAQ) with North American, Japanese and European operations, and branches or authorized distributorships in over 60 countries.
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