“The Dual Wavelength PicoWay® Laser will be featured at the American Society of Dermatological Surgery Meeting, San Diego which is to be conducted on 6th-9th November 2014 with an immediate launch in the US”
A leading global aesthetic device company Syneron Medical Ltd, announced the clearance of its new PicoWay picosecond device by the US Food and Drug Administration (FDA) for removal of tattoos. PicoWay is a state-of-the-art dual wavelength device, with 1064nm and 532nm wavelengths, which utilizes the proprietary PicoWay TechnologyTM to generate picosecond pulses for removing the tattoos.
The company received clearance for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength.
PicoWay incorporates picosecond (one trillionth of a second) pulse duration and generates picosecond pulses and very high peak power of laser energy on the skin for the treatment of pigmented lesions and tattoos. This high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink.
This innovative PicoWay Technology is proven and reliable platform which offers high performance and low cost of ownership.
The performance of the PicoWay system was evaluated in a prospective, US multicenter study conducted by primary investigators Eric Bernstein, MD, Arielle Kauvar, MD, and Tina Alster, MD. A large majority of subjects (86%) achieved at least 50% tattoo clearance after only 3 treatments based on blinded, independent review. The device proved to be safe enough with no device-related serious adverse events, and low levels of pain and discomfort was observed in the candidates throughout the study.
Chief Executive Officer of Syneron Candela, Amit Meridor, said that, “We expect a strong interest in PicoWay. Tattoo removal represents a significant market opportunity, with estimates that of the 45 million Americans with at least one tattoo, 20% want to have their tattoo removed. PicoWay provides a powerful new option, which clinical trials have shown to offer high rates of tattoo removal in very few treatments.”
It was further elobrated by Dr. Shimon Eckhouse, Chairman of the Board of Syneron Candela that, “PicoWay represents a new era in aesthetic and dermatologic laser applications due to its mechanism of action which is mainly based on the photomechanical (photo-acoustic) effect compared to photo-thermal effect which is used in longer pulse duration aesthetic laser and IPL devices.
With the shortest picosecond pulse and the highest peak power on the market the PicoWay enables efficient tattoo removal with less treatment sessions, more comfort to patients and new revenue streams for our customers.
The different mechanism of action of the PicoWay turns it into a new aesthetic platform with wide range of new aesthetic applications that our scientists and doctors are working on. The highly trusted, reliable Candela platform used on the PicoWay was demonstrated in the multi-site clinical trials performed with the device in the US and internationally on a wide range of indications. This very high reliability and ease of use for the doctor are important advantages of the PicoWay”.
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