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Home » Nail Fungus » Japan approves NuvoLase Inc. PinPointe™ FootLaser™ in Japan

Japan approves NuvoLase Inc. PinPointe™ FootLaser™ in Japan

October 21st, 2012 Nail Fungus

Japanese Ministry of Health,Labor and Welfare has approved NuovoLase Inc.’s PinPointe Foot Laser to be  market in Japan . According to the article at Financal Post.com

“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.”

It’s a great news for all the japanese citizens who suffer of Nail fungus and can not take medications to solve their problem.

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