Cutera wins Health Canada clearance for Pearl Fractional laser

FEBRUARY 1, 2009--Cutera (Brisbane, CA), provider of laser and other light-based aesthetic systems worldwide, says Health Canada has approved its Pearl Fractional system for laser resurfacing of skin and laser treatment for wrinkle reduction. The device received FDA and CE Mark approval in 2008. Cutera says it is the only fractional ablative laser based on the 2790 nm wavelength with proprietary YSGG technology, and as such enables deep ablation with a controlled zone of thermal coagulation.

FEBRUARY 1, 2009--Cutera, Inc. (Brisbane, CA) (CUTR) provider of laser and other light-based aesthetic systems for practitioners worldwide, says Health Canada has approved its Pearl Fractional for laser skin resurfacing and the treatment of wrinkles. The device received FDA clearance and CE Mark approval in 2008, and augments Cutera's original Pearl system. A recent survey of patients revealed that 95% would recommend Pearl Fractional treatment.

"Pearl Fractional shipments are commencing immediately into the Canadian market," Cutera President and CEO Kevin Connors said. "This approval confirms that Pearl Fractional meets all health, safety, and environmental standards required by Canada's Ministry of Health."

"Pearl Fractional is designed to safely and effectively repair deep dermal imperfections in just one treatment with an average recovery of five days," Connors continued. "And our customers' outstanding clinical results and histology data support that it's working. A recent study revealed that 94 percent of patients were pleased to extremely happy with their treatment results and 95 percent of patients would recommend a Pearl Fractional treatment."

"Pearl Fractional can be used on the entire face or just problem areas. It is especially good for treating the periorbital, perioral and jawline areas," said Brian Biesman, M.D., medical director of the Nashville Centre for Laser and Facial Surgery in Nashville, TN and current president of the American Society for Laser Medicine and Surgery.

Biesman continued, "When combined with Cutera's Pearl laser for full epidermal renewal, I have a unique solution for a deep and full coverage treatment. My patients are thrilled to see improvements in not only their wrinkles, but also with their uneven skin texture, pigmentation and sun damage. Pearl and Pearl Fractional offer a unique and outstanding option for skin rejuvenation."

According to Cutera, Pearl Fractional is the only fractional ablative laser based on the 2790 nm wavelength with proprietary YSGG technology. Due to its specific water absorption characteristics, 2790 nm is an optimal laser wavelength for providing the dual benefit of deep dermal ablation with a controlled zone of thermal coagulation to maximize results while minimizing post-operative downtime.

Pearl Fractional received FDA clearance and CE Mark approval in 2008.

More information:
Cutera's website

Posted by Barbara G. Goode, barbarag@pennwell.com.

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