CHICO, Calif.--(BUSINESS WIRE)-- NuvoLase Inc. is pleased to announce they have received their own CE mark of approval for the PinPointe FootLaser. NuvoLase received ISO 13485 certification for its Quality Management System in September 2012, an approval only granted to companies who uphold the highest standards of design, manufacturing, and production for all its products and who show the intention and preparedness to continue to refine them moving forward. Now NuvoLase has been granted the CE Mark, which will allow it to continue to serve customers throughout the European Union (EU) under the NuvoLase organization.
"We've been working diligently to uphold the promises we made to our shareholders and our customers," says Steven P. Duddy, President and Chief Executive Officer of NuvoLase Inc. "We are determined to continue to bring the PinPointe FootLaser to as many patients as possible, and naturally it is critical for us to obtain the approvals of every country where this technology can benefit patients. We're pleased to add the European Union to that rapidly-growing list."
What makes the PinPointe FootLaser so valuable to clinicians throughout the world? "Onychomycosis - most recognize it as 'nail fungus' - is the most common disease of the nails and effects nearly 10% of the global population," Duddy explains. "That's an enormous number of people globally. It doesn't get a lot of attention, but these infections can be very painful, unsightly and surprisingly difficult to treat. Oral medication had serious potential risks to the patient, and few are willing to risk their overall health to treat nail fungus, however severe it might be."
NuvoLase has also received their own medical device license issued by Health Canada for the PinPointe FootLaser.
“We're pleased with our progress to date," says Duddy. "Achieving these approvals from so many countries wouldn't have gone nearly as smoothly or quickly if we didn't have such high standards for our products. We're not trying to achieve the bare minimum requirement for any given market - we always seek to create the very best treatment we possibly can."
Clinicians interested in learning more about the PinPointe FootLaser or in purchasing one for their business can contact NuvoLase’s distribution partner, Cynosure Inc., directly at 800-886-2966 or visit their website at www.cynosure.com.
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.
Steve Duddy, 530-809-1970