IRVINE, California,
July 25, 2016 /PRNewswire/
-- Syneron Medical Ltd. (NASDAQ:ELOS), a leading global
aesthetic device company, announced today that the
PicoWay® picosecond laser received U.S. Food and Drug
Administration (FDA) clearance for a new ultra-short 785nm
wavelength, which is the third FDA cleared wavelength for PicoWay.
The new ultra-short 785nm wavelength is the first of its kind in
the aesthetic market, utilizing a titanium sapphire laser for the
removal of blue and green inks, and will be available to new and
existing PicoWay customers in the U.S. market in the fourth quarter
2016.
The FDA clearance of the new ultra-short 785nm wavelength was
supported by a 15 patient study, covering 22 tattoos, of which 18
contained blue and green inks. Blinded evaluation of tattoo
clearance, by independent board-certified physicians, showed that
83% of the treated blue/green tattoos had "good" to "complete"
treatment response after 2 PicoWay treatments with the 785nm
wavelength. Moreover, investigator assessments of tattoo clearance
showed similar results to blinded evaluation findings. There were
no treatment complications, and PicoWay treatments were generally
associated with no discomfort to mild discomfort for the majority
of treatments.
Eric F. Bernstein, MD, MSE,
Director of the Main Line Center for Laser Surgery in suburban
Philadelphia, PA, and Chairman of
the Candela Laser Corporation Medical Advisory Board, was the
principal investigator for the clinical study resulting in FDA
clearance of the new 785nm wavelength for PicoWay laser. Dr.
Bernstein commented, "This is the first, ever, 785nm wavelength
picosecond-domain laser in the world. This novel addition to the
PicoWay enables optimal treatment for blue and green tattoos, and
is a welcome addition to the 532 and 1,064nm wavelengths already
available with the PicoWay. I am extremely impressed with
Jay Bhawalkar and his engineering
team at Candela, who developed the PicoWay. The new 785nm
wavelength further enhances the already strong capabilities of the
PicoWay platform for tattoo removal, adding to its ability to
rapidly and safely clear multicolored tattoos. I am thrilled to
offer this new wavelength to my patients, and honored to have lead
the clinical trial leading to FDA clearance of the PicoWay and this
new wavelength."
The innovative PicoWay laser platform delivers ultra-short
pulses of energy (e.g., 300 picoseconds at 785nm) making treatments
shorter and comfortable for patients while offering the industry's
shortest pulses and highest peak power. The addition of PicoWay's
third wavelength completes the PicoWay laser platform, allowing for
the comprehensive removal and treatment of all colors of tattoos
and pigmented lesions. The PicoWay picosecond laser previously
received FDA clearance for the removal of tattoos in November 2014 and the treatment of pigmented
lesions in April 2015.
Amit Meridor, Chief Executive Officer of Syneron Medical,
said, "We are pleased to receive FDA clearance for the new
785nm wavelength for PicoWay, which enhances its ability to remove
blue and green tattoo ink. With the addition of this third
wavelength, PicoWay can now provide practices with the ability to
provide comprehensive removal and treatment of all colors of
tattoos and skin pigmentation. We look forward to making this
feature available to new and existing PicoWay customers in the U.S.
beginning in the fourth quarter."
About Syneron Candela:
Syneron Candela is a leading global aesthetic device company
with a comprehensive product portfolio and a global distribution
footprint. The Company's technology enables physicians to
provide advanced solutions for a broad range of medical-aesthetic
applications including body contouring, hair removal, wrinkle
reduction, tattoo removal, improving the skin's appearance through
the treatment of superficial benign vascular and pigmented lesions,
and the treatment of acne, leg veins and cellulite. The Company has
a wide portfolio of trusted, leading products including UltraShape,
VelaShape, GentleLase, VBeam Perfecta, PicoWay, CO2RE,
CO2RE Intima*, Profound and elōs Plus.
Founded in 2000, the corporate, R&D, and manufacturing
headquarters for Syneron Candela are located in Israel.
Syneron Candela also has R&D and manufacturing operations in
the U.S. The company markets, services and supports its
products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan,
and Hong Kong and distributors worldwide.
For additional information, please
visit http://www.syneron-candela.com.
Syneron, the Syneron logo, UltraShape, eMatrix and elōs are
trademarks of Syneron Medical Ltd. and may be registered in certain
jurisdictions. The elōs (Electro-Optical Synergy) technology is a
proprietary technology of Syneron Medical Ltd. All other names are
the property of their respective owners.
* CO2RE Intima is a module of the CO2RE system.
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Syneron Contacts:
Hugo Goldman, Chief Financial
Officer, Syneron Medical
Email: hugo.goldman@syneron.com
Zack Kubow, The Ruth Group
+1-646-536-7020
Email: zkubow@theruthgroup.com
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SOURCE Syneron Medical Ltd.