Cutera Receives FDA 510(k) Clearance for enlighten^TM

Date Announced: 12 Aug 2014

First and Only FDA-Cleared Dual Wavelength and Dual Pulse Duration Laser Featuring Picosecond Technology.

BRISBANE, Calif., Aug. 12, 2014 (GLOBE NEWSWIRE) -- Cutera, Inc. (CUTR), a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced that its enlighten laser platform received U.S. Food and Drug Administration 510(k) clearance 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.

"The enlighten FDA clearance represents a critical milestone in bringing this industry-changing technology to market. Following the success of our excel V^TMand excel HR^TM 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.

"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," said Kevin Connors, President and CEO of Cutera, Inc.

E. Victor Ross, M.D., a board certified Dermatologist at Scripps Clinic in San Diego and one of the leading experts in aesthetic laser technology commented "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. We are actively investigating how enlighten might address many skin and aesthetic concerns and look forward to moving the field forward with our research."

Commercial shipments of enlighten are anticipated to commence in the fourth quarter of 2014.

Source: Cutera

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