Syneron Candela picosecond laser for tattoo removal receives FDA clearance

Aesthetic laser maker Syneron Medical (NASDAQ: ELOS; Wayland, MA) has received FDA approval for its PicoWay picosecond laser. The dual-wavelength device, with 1064 and 532 nm wavelengths, utilizes the company's PicoWay technology to generate picosecond pulses for tattoo removal of all colors. The laser's U.S. launch will begin immediately, following the launch of the product in the international market in October 2014.

The laser, which integrates the company's PicoWay technology into a Syneron Candela platform, incorporates picosecond pulse duration to generate an ultrashort pulse and very high peak power of laser energy on the skin. The high-energy, ultrashort picosecond laser pulse creates a strong photomechanical impact that optimizes fracturing of tattoo ink.

The laser was evaluated in a prospective, U.S. multicenter study conducted by Eric Bernstein, MD, Arielle Kauvar, MD, and Tina Alster, MD, as the primary investigators. A large majority of subjects (86 percent) achieved at least 50-percent tattoo clearance after only three treatments based on blinded, independent review. Device treatment also presented a favorable safety profile with no device-related serious adverse events, and low levels of pain or discomfort throughout the study.

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