Orangeburg, New York: New indication expands applications for the company’s SkinStation® Clinical Phototherapy System.
Radiancy, Inc., the global leader in light-based skin therapies, has received U.S. Food and Drug Administration (FDA) 510(K) clearance to market the company's Hair Removal (HR) Pro Light Unit Assembly (LUA) to treat Fitzpatrick Skin Types V-VI. The new indication for the HR Pro V-VI LUA increases the treatment applications available with Radiancy’s LHE® based phototherapy systems, including SkinStation® , the company’s leading product in the United States .
Previously cleared for all skin types in the treatment of acne vulgaris, as well as pigmented and vascular lesions, this expanded indication for hair removal in Fitzpatrick Skin Types V-VI provides additional treatment benefits to both physicians and patients.
“Physicians now have a clinically proven phototherapy modality for safe and effective hair removal in the treatment of all Fitzpatrick skin types,” says Fabian Tenenbaum, vice president of marketing and sales for Radiancy. “This new indication underscores the value of SkinStation in the treatment of the most common skin conditions presented in today’s professional skin care practices.”
According to Neil Sadick, M.D., whose private practice Sadick Dermatology is located in New York City , the specific goal of the three-month long clinical research program was to assess if darker skin types could be successfully treated with the HR Pro V-VI LUA. “Effective hair removal in dark-skinned individuals was achieved with few side effects,” explains Dr. Sadick. “Our investigation showed that the HR Pro V-VI LUA was an easy-to-use, reliable, an economical way to remove hair in dark skin phenotypes.”
Another principal investigator involved in the research program was Dr. Yoseph Krespi of the Head & Neck Surgical Group, with 4 locations throughout New York City . “We used to reject darker skin types as poor candidates for light-based hair removal”, said Dr. Krespi. “Now with this new indication, we are comfortable in recommending the therapy as safe and effective for this particular patient population.”
Dr. Krespi continues, “Our research established safe performance parameters in the treatment of skin types V-VI. We use the system every day and it has proven to be highly reliable. The modular, tabletop design and lightweight, flexible hand piece is easy to manipulate over a wide surface area, reducing treatment times.” Based on density and location of hair—upper lip and chin hair being more problematic—Dr. Krespi suggests a treatment regimen of four to eight sessions.
“This newest hair removal indication for Fitzpatrick Skin Types V-VI augments the commitment of Radiancy to provide clinically proven, consistently safe treatment solutions for a wide spectrum of dermatological applications,” confirms Tenenbaum.
Psoriasis indication currently under FDA review
Also of note, Radiancy, Inc. has recently filed for FDA 510(K) clearance for the company’s LHE based Light Unit Assembly used in the treatment of psoriasis. The company anticipates a rapid review, and is hopeful for market clearance in the 4 th Quarter of this year.