Cutera, a Brisbane, California-based provider of laser and other light-based aesthetic systems, has received the US Food and Drug Administration (FDA) 510(k) approval for GenesisPlus laser to treat onychomycosis, a nail fungus often causes the toenails to become discolored, thickened and separated from the nail bed.
GenesisPlus utilizes Cutera’s patented microsecond technology and features a proprietary delivery system with a temperature sensor to improve the practitioner and patient experience.
Onychomycosis current treatment options include prescription topicals and oral drugs, both with limited success rates.
Cutera president and CEO Kevin Connors 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," Connors said.