FDA approves laser device for treatment of nail fungus
Chico, Calif. — The PinPointe FootLaser, made by PinPointe USA, based here, has received Food and Drug Administration (FDA) clearance for the treatment of onychomycosis, Marketwire reports.
During treatment, the administering physician directs the specially designed laser beam across the nail. The laser penetrates the nail bed, targeting the fungi but leaving the nail and surrounding healthy tissue intact.
According to Marketwire, PinPointe submitted clinical evidence to the FDA showing that after one treatment, between 68 percent and 81 percent of patients experienced increased clear nail at six and 12 months, and that 81 percent of all patients had sustained improvement at 12 months.
Onychomycosis is estimated to affect about 35 million Americans.