Laser treatments for toenail fungus:
GenesisPlus Receives FDA Clearance
BRISBANE, CA- April 7, 2011-- Cutera, Inc. (NASDAQ: CUTR), a leading worldwide provider of laser and light-based aesthetic systems for practitioners worldwide, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its GenesisPlus. The complete list of the indications for use for the GenesisPlus laser can be found in the FDA 510(k) clearance number (K) 103626.
Known medically as onychomycosis, nail fungus often causes the toenails to become discolored, thickened and separated from the nail bed. Approximately half of the population will have at least one infected toenail during the course of their lives. Current treatment options for toenail fungus include prescription topicals and oral drugs, both with limited success rates. Some patients are not candidates for oral medications to treat toenail fungus, due to concerns of liver damage and other treatment limitations.
"The GenesisPlus laser is a great innovation in the treatment of fungal nails and it has exceeded my expectations for safety and efficacy," said David Weiss, Doctor of Podiatric Medicine in private practice in Hammonton, NJ. "The options I've had in the past were limited because they didn't work very well and patients were concerned about side effects."
GenesisPlus utilizes Cutera's patented microsecond technology and features a proprietary delivery system with a temperature sensor to improve the practitioner and patient experience. "What impresses me about the GenesisPlus is the safety, effectiveness and speed of the treatments. In one 10-15 minute session, I can treat a patient who has been suffering for years with unsightly, deformed and discolored toenails," said Jeffrey Kleis, Doctor of Podiatric Medicine in private practice in Beverly Hills, CA. "There is no downtime and my patients have been extremely pleased."
Kevin Connors, President and CEO of Cutera said, "A significant number of affected patients are dissatisfied with the current treatment options for toenail fungus, including topical therapies and oral medications. The GenesisPlus provides a fast and effective solution for onychomycosis, without the risks of serious side effects."