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Cutera Receives FDA 510(k) Clearance for Laser

Cutera, Inc. received FDA clearance for its enlighten laser platform for the treatment of benign pigmented lesions. Enlighten is the first and only dual wavelength (532 nm/1064 nm) and dual pulse duration picosecond laser system cleared for sale in the United States. Commercial shipments of enlighten are anticipated to commence in the fourth quarter of 2014.

“The enlighten FDA clearance represents a critical milestone in bringing this industry-changing technology to market. Following the success of our excel V and excel HR laser systems, enlighten is the third and latest platform showcasing Cutera's innovations in laser and light technology, as well as advanced micro-electronics, efficient power generation, and ergonomic design,” says Kevin Connors, President and CEO of Cutera Inc.

“The system's dual wavelengths, dual pulse durations, high power and independent adjustment of fluence and spot size are all industry-leading features that provide practitioners with the broadest range of treatment settings. Beyond the treatment of benign pigmented lesions, enlighten is pending 510(k) clearance for tattoo removal. We fully anticipate that enlighten will lead the next generation of multi-application laser platforms," says Connors.

“Picosecond pulses, which are on the order of trillionths of a second, are one of the most exciting technology innovations within the aesthetic laser and light-based industry. With enlighten, the medical community has a high power, versatile picosecond device that allows practitioners to fully leverage the clinical possibilities of extremely short pulse duration treatments,” adds E. Victor Ross, MD, a board certified dermatologist at Scripps Clinic in San Diego. “We are actively investigating how enlighten might address many skin and aesthetic concerns and look forward to moving the field forward with our research.”

 

 

 

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