FDA Approves Syneron Aurora for
Acne Treatment
YOKNEAM, Israel & TORONTO --(Business
Wire)-- Feb. 5, 2004 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 Aurora AC(TM) system for treatment of moderate
inflammatory acne vulgaries. The system, comprising a special applicator for acne
treatment and the Aurora medical aesthetic treatment platform, has already received CE
Mark approval, enabling it to be marketed in Europe and other regions.
Over the past year and a half, Syneron
has secured FDA approval for systems that treat a wide range of medical aesthetic
conditions, including the Aurora SR skin renewal system and the Aurora DS hair removal
system. Its other product family, Polaris, addresses wrinkle treatment, hair removal, and
vascular lesion and leg vein treatment.
Aurora AC 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. Like all Aurora systems, Aurora AC uses light and
conducted RF energies.
"This FDA approval is an important
step as it establishes Syneron as the only company that can offer skin renewal, hair
removal and acne treatment via a single platform," said Domenic Serafino, President
of Syneron Medical Inc. "This means that our customers can cost effectively treat a
wide range of patients and conditions."
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 www.syneron.com.
