Syneron Candela Announces FDA Clearance of PicoWay Picosecond Laser for Tattoo Removal


The FDA granted 510(K) clearance to Syneron Candela's PicoWay picosecond device for tattoo removal. PicoWay is a dual wavelength device, with 1064nm and 532nm wavelengths, which utilizes the proprietary PicoWay Technology to generate picosecond pulses for the removal of tattoos. The FDA clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength. The US launch of PicoWay will begin immediately, following the launch of the product in the international market in October, according to the company.

PicoWay incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink. The innovative PicoWay Technology is integrated into a proven, reliable Syneron Candela platform which offers high reliability, superior performance and low cost of ownership.

In support of the FDA 510(K) clearance, the performance of the PicoWay system was evaluated in a prospective, US multicenter study conducted by Eric Bernstein, MD, Arielle Kauvar, MD, and Tina Alster, MD as the primary investigators.  A large majority of subjects (86%) achieved at least 50% tattoo clearance after only 3 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.  

Dr. Eric Bernstein, President of Main Line Center for Laser Surgery, said, "PicoWay is an innovative and exciting breakthrough for tattoo removal. As a dual wavelength Nd:YAG laser, it delivers extremely high peak-power, picosecond pulses enabling the treatment of all skin types. What this means is extremely impressive results, which translate into very happy patients. PicoWay is a game-changing laser for tattoo removal, and could not have come at a better time." 

Amit Meridor, Chief Executive Officer of Syneron Candela, said, "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."

Dr. Shimon Eckhouse, Chairman of the Board of Syneron Candela commented, "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".

Dr. Arielle N.B. Kauvar, Clinical Professor of Dermatology at New York University, said, "The PicoWay laser allows us to treat a broader range of skin types and a wide array of tattoo ink colors. With the ultra-short picosecond pulse duration, there is minimal discomfort during treatment.  Professional and multicolored tattoos are cleared in very few treatment sessions offering greater patient convenience compared to longer treatment regimens."

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