PALO ALTO, Calif, December 15, 2011 — Sciton, a leading manufacturer of high-quality custom, modular, multi-application medical laser, and light-based systems, announced today that the U.S. Food and Drug Administration (FDA) has cleared Sciton’s JOULE for patients with onychomycosis. The JOULE includes a versatile, laser delivery technology with real-time temperature feedback for the safe and effective cosmetic improvement of dermatologic conditions including onychomycosis. The complete list of JOULE ClearSense indications for use can be found in the FDA 510(k) clearance number (K) 111483.
Worldwide, it is reported that onychomycosis, affects up to 5 percent of the population. The condition can lead to embarrassing and unsightly nails and even pain. Current treatment options range from home remedies to over-the-counter topical creams to prescription-based oral medications that can be highly toxic to liver function. The FDA’s clearance of Sciton’s JOULE ClearSense will allow practitioners to treat the millions of people affected by onychomycosis.
“Finally, we have a safe treatment option that works for treating onychomycosis. ClearSense is a definite advancement for the podiatry and dermatologic fields, offering patients and practitioners a reliable method to treat unsightly nail fungus without toxic side effects,” said Thomas Bembynista, DPM, Podiatrist in Independence, Missouri.
Jill S. Waibel, MD, founder, and owner of the Miami Dermatology & Laser Institute in Miami, Florida, commented, “Onychomycosis can be very challenging to treat with the options we have traditionally had. Patients who have never before had any success with other fungal therapies are seeing significant improvements in their affected nails using ClearSense.”
With Sciton’s commitment to offering maximum flexibility on a single platform, physicians can also treat additional dermatologic indications, including but not limited to warts. “The FDA’s clearance of Sciton’s ClearSense for patients with onychomycosis represents a new chapter for those suffering from a fungal infection of their nails. Sciton continues our commitment to offering versatile, cutting-edge technology, which enable doctors to offer safe and very effective treatments,” stated Dan Negus, President of Sciton.
Sciton, Inc., located in Palo Alto, California, is a totally employee-owned medical device company established in 1997 by co-founders Jim Hobart, Ph.D., and Dan Negus, Ph.D. Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance, and value. Sciton offers aesthetic and medical devices for women’s health, fractional and full-coverage skin resurfacing and skin revitalization, phototherapy, vascular and pigmentation lesions, scar reduction, acne, body contouring, and hair reduction. Sciton operates worldwide with direct sales forces in the United States, Canada, Japan, Australia, and distributor partners in more than 45 countries. For more information and a complete listing of Sciton systems, visit sciton.com.