Syneron Bags FDA Clearance - Analyst Blog

Syneron Medical Ltd. (ELOS), a worldwide aesthetic products company, recently announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market its latest Tanda Light Emitting Diode (“LED”) to be utilized for skin rejuvenation.

The new skin rejuvenation system is authorized to treat rhytides, wrinkles and lines in the periorbital region (surrounding the eye). The company expects to commercialize the system in the second half of the current year, in both the consumer and professional segments.    

According to Syneron, its new Tanda Professional Rejuvenate red light home use instrument is a useful addition for customers who seek to cut down on wrinkles around the eyes with sophisticated home light source. This technology provides a safe treatment option for dermal rejuvenation, which effectively enhances collagen production while enhancing dermal moisture. The company believes that its new system will expand the indications for its Tanda LED technology.

The Tanda skin rejuvenation system joins the Tanda line of products from the former Pharos Life Corporation (a producer of home-use light therapy devices for aesthetic procedures), which was acquired by Syneron last month. This device uses an in-house luminous LED array that provides concentrated streams of light for fractional phototherapy effect.

This highly luminous LED enables the new Tanda system to deliver five-times more power than the existing Tanda line of products, thereby cutting down the requisite number of treatments to two each week. The system builds upon the modular design of the Tanda group of products.

Syneron (founded in 2000) markets Tanda products, directly to customers, through premium retailers. Its product line-up includes items for skincare for both the home-use and professional segments. The company markets and supports its products in about 90 nations.

Syneron offers a comprehensive aesthetic product portfolio and a global distribution setup. Its knowledge allows medical practitioners provide sophisticated solutions for a wide range of aesthetic requirements such as wrinkle reduction, hair removal and body contouring. Syneron markets its products under two brands, Syneron and Candela.  It competes with Cutera Inc. (CUTR) among others.

 
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