FDA Clears Syneron VelaSmooth for Cellulite Treatment
13 Junio 2005 - 12:08PM
PR Newswire (US)
FDA Clears Syneron VelaSmooth for Cellulite Treatment YOKNEAM,
Israel, and TORONTO, June 13 /PRNewswire-FirstCall/ -- Syneron
Medical Ltd. (NASDAQ:ELOS) today announces the US Food & Drug
Administration (FDA) has granted 510(k) pre-marketing clearance to
Syneron's VelaSmooth medical device, powered by elos, for the
temporary reduction in the appearance of cellulite. The VelaSmooth
also received clearance for the relief of minor muscle aches, pain
and spasm and the temporary improvement of local blood circulation.
The clearance of the VelaSmooth offers a new non-surgical, no
downtime alternative for patients wishing to treat the appearance
of cellulite. "The VelaSmooth incorporates a combination of
technologies enabling deeper heating and mechanical manipulation of
cellulite in a non-invasive manner," said Dr. Tina Alster, director
of the Washington Institute of Dermatologic Laser Surgery and
clinical professor of dermatology at Georgetown University. "In our
clinical study of 20 women of various ages and skin types with
moderate thigh and buttock cellulite, significant clinical
improvement was observed in skin contour irregularities, and thigh
circumferences were also reduced. Patients didn't lose weight, but
they looked as if they had. Our research has shown that it is no
longer necessary to endure painful and lengthy recovery times or be
exposed to general anesthesia that is typical of other procedures
like liposuction in order to achieve improvement of cellulite." In
addition to the 510(k) clearance, the FDA created a new product
code for the VelaSmooth, confirming its unique position in the
aesthetic device market. According to Dr. Amir Waldman, head of
Clinical and Regulatory Affairs for Syneron, "The FDA's designation
of a new product category specifically for the VelaSmooth reaffirms
how technically innovative this device is for the treatment of
cellulite." Cellulite is a term used to describe the pitting,
bulging and deformation of the skin usually affecting the thighs,
buttocks, hips, breasts and the abdomen of women. More than 80
percent of women above the age of 18 have cellulite, regardless of
their size, weight or physical fitness. Women are more likely to
have cellulite than men as men's fat cells reside deeper within the
skin, while women's are closer to the surface, causing the ripples
associated with cellulite. "It is important for potential patients
to understand that the VelaSmooth has been cleared by the FDA as a
medical device," said Domenic Serafino, president of Syneron
Medical Inc. "Many companies offer lotions and devices that have
claimed to have effectively treated cellulite. We are proud to be
the only company that has gone through the exercise of clinical
studies with more than 500 patients to verify the efficacy of the
treatment." The VelaSmooth system, like all of Syneron's medical
aesthetic devices, is powered by elos(TM) (Electro-Optical
Synergy). Elos, the first and only combined energy technology, uses
Bi-Polar Radio Frequency (RF) and Infrared Light energy along with
the added feature of negative pressure tissue mobilization. The
synergy of the three components makes VelaSmooth an effective
treatment for those seeking a medical cellulite solution. Because
it is a cleared medical device, the VelaSmooth is only sold to
physicians for use by trained professionals under their medical
direction. About Syneron Syneron Medical Ltd. (NASDAQ:ELOS)
manufactures and distributes medical aesthetic devices that are
powered by the proprietary, patented elos(TM) combined-energy
technology of Bi-Polar Radio Frequency and Light. The Company's
innovative elos technology provides the foundation for highly
effective, safe and cost-effective systems that enable physicians
to provide advanced solutions for a broad range of
medical-aesthetic applications including hair removal, wrinkle
reduction, rejuvenating the skin's appearance through the treatment
of superficial benign vascular and pigmented lesions, and the
treatment of acne, leg veins and cellulite. Founded in 2000,
Syneron Medical Ltd. has offices and distributors throughout the
world including North American Headquarters in Canada and European
Headquarters in Germany, which provide sales, service and support.
Additional information can be found at http://www.syneron.com/. For
more information, please contact: Syneron North America Media
Domenic Serafino, President Schwartz Communications North America
Lloyd Benson/Jane Sinclair (905) 886-9235 ext. 247 (781) 684-0770
Syneron, the Syneron logo, elos, and VelaSmooth 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. DATASOURCE: Syneron Medical Ltd. CONTACT:
Domenic Serafino, President of Syneron North America, +1-905-
886-9235 ext. 247, ; or Lloyd Benson or Jane Sinclair, both of
Schwartz Communications, +1-781-684-0770, Web site:
http://www.syneron.com/
Copyright
Syneron Medical Ltd. - Ordinary Shares (NASDAQ:ELOS)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Syneron Medical Ltd. - Ordinary Shares (NASDAQ:ELOS)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024