GenesisPlus Receives FDA Clearance for Onychomycosis (CUTR)

Cutera CUTR today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its GenesisPlus. The complete list of the indications for use 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 include prescription topicals and oral drugs, both with limited success rates. Some patients are not candidates for oral medications, due to concerns of liver damage and other treatment limitations. Kevin Connors, President and CEO of Cutera said, "A significant number of affected patients are dissatisfied with the current treatment options, including topical therapies and oral medications. The GenesisPlus provides a fast and effective solution for onychomycosis, without the risks of serious side effects."