CHICO, Calif.--(BUSINESS WIRE)--NuvoLase Inc. announced today that it received shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its PinPointe FootLaser in Japan.
“I am pleased and excited about receiving MHLW approval for our PinPointe FootLaser in Japan,” says Steven P. Duddy, President and Chief Executive Officer of NuvoLase Inc. “The PinPointe FootLaser has quickly become the light-based treatment of choice for many clinicians seeking alternative treatment methods for onychomycosis (nail fungus). The FootLaser is an effective alternative to oral medications, which can be risky for the patient.”
The PinPointe FootLaser was the first light-based device to receive FDA clearance specific to onychomycosis, commonly known as nail fungus. With almost 100,000 procedures performed worldwide with the PinPointe FootLaser, the FootLaser remains one of the only devices on the market today with documented clinically proven efficacy.
The MHLW approval in Japan is the most recent of regulatory clearances for the PinPointe FootLaser, adding to its existing regulatory approvals which include FDA clearances, CE Mark, TGA and Health Canada.
NuvoLase was also recently granted ISO 13485 certification for its Quality Management System, indicating that the company is committed to high design, manufacturing, and production standards for its products and is poised to continue to refine them moving forward.
“We’re working to expand to as many markets as possible, both domestically and abroad,” Duddy explains. “We’ll continue to invest in science, technology, intellectual properties and clinical studies that will help us expand our applications, create new beneficial products, and garner regulatory clearances worldwide.”
About NuvoLase Inc.
NuvoLase, Inc. develops and markets innovative devices for healthcare providers worldwide. NuvoLase products are the result of solid research, sound science, and extensive clinical experience, ensuring that they always provide superior clinical performance. The PinPointe FootLaser is available worldwide. For more information, visit our website at www.NuvoLase.com.
NuvoLase, PinPointe, and PinPointe FootLaser are trademarks of NuvoLase, Inc.
11 Ilahee Lane
Chico, CA 95973
Patients seeking additional information or a doctor in their area who offers the PinPointe FootLaser procedure can call 1.877.ToeNail (1.877.863.6245) or visit www.PinPointeFootLaser.com/patients/find-a-provider.
Clinicians interested in learning more about the PinPointe FootLaser or interested in purchasing one for their practice can contact NuvoLase’s distribution partner, Cynosure Inc., directly at 800-886-2966 or visit their website at www.cynosure.com.
Steven P. Duddy, 650-918-8596