CoolTouch Receives FDA Clearance for VARIABreeze™ Laser for Patients with Toenail Fungus
ROSEVILLE, CA. (November 3, 2011) – CoolTouch Inc, manufacturer of medical laser devices, announced today their VARIABreeze ™ 1064nm laser system has received FDA clearance (K103338) for the temporary increase of clear nail in patients with onychomycosis or toenail fungus. Nail fungus is the cause of yellow, thick, brittle nails. Approximately 36 million people in the US suffer with nail fungus, with 700 million afflicted worldwide.
“This FDA clearance is a milestone for CoolTouch, physicians and patients alike. The CoolBreeze treatment provides clearing of nails without the risks of oral medications and the strict regimen of topical creams.” states CoolTouch CEO David Hennings.
The CoolBreeze laser procedure itself takes only twenty minutes. Patients begin to see improvement in their nail appearance within weeks. Those treated prefer the laser procedure, as it is safer than oral medications and easier to comply with than topical solutions. The CoolBreeze laser treatment is available at your podiatrist or dermatologist’s office. It is fast, safe, effective and painless and you can get back to work and play the same day as the treatment.
CoolTouch Inc. is a leading U.S.-based developer and manufacturer of innovative, advanced laser products for medical professionals. Engineering and science-based, CoolTouch is considered a pioneer in the medical and aesthetics technology industry. CoolTouch introduced the first 1320 nm wavelength laser to medical professionals for non-ablative wrinkle treatment in 1994. They continued setting new standards in the industry with the launch of the CTEV for varicose vein treatment and with CoolLipo™ for laser lipolysis and skin tightening. CoolTouch products are manufactured in Roseville, Calif.