Source: Syneron Medical Ltd.
Syneron Medical Ltd., and its North American subsidiary Syneron Inc.,
today announced that the US Food & Drug Administration (FDA) has
granted 510K marketing clearance to Syneron's Polaris WR(TM) system
for non invasive wrinkle treatment. This is the third Polaris system
approved by the FDA. Polaris DS is approved for hair removal and
Polaris LV for vascular lesion and leg vein treatment. All three
Polaris systems have already received CE Mark approval, enabling them
to be sold in Europe and other parts of the world.
Polaris WR utilizes Syneron's proprietary ELOS(TM) (Electro-Optical
Synergy) technology, which combines optical energy and electrical
energy to enable a wide range of highly efficient, safe and
cost-effective medical aesthetic treatment systems. All Polaris
systems use diode laser energy combined with conducted RF energy.
Syneron's flagship family of Aurora systems is unique in its use of
light energy and conducted RF energy.
"The technology and application methodology utilized by Polaris WR
differ significantly from those of other wrinkle treatment systems
currently available," said Michael Kreindel, Ph.D., CTO of Syneron
Medical Ltd. "Only Polaris WR works on both the dermis and the
epidermis, which enables more effective treatment of a wide range of
periocular and other facial wrinkles."
Michael I. Kulick, MD, a leading plastic surgeon in San Francisco, CA
noted: "In clinical trials, the Polaris WR system provided outstanding
efficacy and safety. The post treatment results demonstrate
significant reduction in the signs of aging. Improvement of wrinkles
in these cases is dramatic and from my experience, is equivalent to
laser resurfacing. Patients with both significant and moderate
hyper-pigmentation and hyper-vascularity were improved. Lack of
complications and minimal downtime place this device in the
non-ablative category."
Domenic Serafino, President, Syneron Medical Inc., said: "With this
third FDA approval for a Polaris system, and the previous approvals
for Aurora systems, Syneron now has two universal platforms that cover
the full gamut of hair removal and skin rejuvenation applications. We
are extremely well positioned to help a broad range of physicians grow
their aesthetic practices."
About Syneron
Syneron is dedicated to maximizing the synergy between electrical
energy and optical energy to provide advanced solutions for a broad
range of medical-aesthetic applications. The Company's innovative
patent-pending ELOS technology provides the foundation for highly
efficient, safe and cost-effective systems that enable physicians and
medical professionals to offer new and improved services to their
patients. Founded in 2000, Syneron's headquarters and R&D center,
Syneron Medical Ltd., is located in Israel. Its sales, service and
support subsidiaries are located in Toronto, Canada (Syneron Inc.) and
Grunwald, Germany (Syneron GmbH). Please visit http://www.syneron.com/
.
For more information, please contact Domenic Serafino, President,
Syneron Inc., at Tel. (866) 259-6661 ext. 247, email:
do...@syneron.com.
For more information, please contact Domenic Serafino, President,
Syneron Inc., at Tel. (866) 259-6661 ext. 247, email:
do...@syneron.com, or Moshe Mizrahy, CEO of Syneron Medical, at Tel.
+972 4 909-7424, email: mos...@syneron-med.com.
Syneron, the Syneron logo, Aurora, the Aurora logo, Polaris, the
Polaris logo and ELOS are trademarks of Syneron Medical Ltd. and may
be registered in certain jurisdictions. ELOS (Electro-Optical Synergy)
is a proprietary technology of Syneron Medical. All other names are
the property of their respective owners.
CONTACT: Domenic Serafino, President of Syneron Inc.,
+1-866-259-6661,ext. 247, do...@syneron.com
Web site: http://www.syneron.com/