Aesthetic products company Syneron Medical has won the 510(k) clearance of the U.S. Food and Drug Administration (“FDA”) to market its new Tanda Luxe Light Emitting Diode (“LED”).
The new skin rejuvenation system has been approved by the regulator for over-the-counter (“OTC”) treatment of periorbital (surrounding the eye) wrinkles, rhytides and fine lines. The Israel-based company plans to start marketing the device in the prestige retail market in the fourth quarter.
The Tanda Luxe skin rejuvenation system, which integrates concentrated red light therapy, sonic vibration and gentle warming, joins the company’s Tanda line of acne and anti-aging products. This comfortable, easy-to-use device uses an in-house super luminous LED array to deliver concentrated streams of red light for fractional phototherapy effect, effectively reversing signs of aging.
Red light has been proven to enhance collagen and elastin (a complimentary protein to collagen) production for a younger looking complexion over time. Tanda Luxe is also proven to increase dermal hydration by 15%.
The new system is compatible with the recently approved Tanda Clear+ acne treatment device. Syneron also launched, in early 2011, the Tanda Zap advanced acne clearing device which is already well received by the customers.
Syneron 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 product portfolio and a global distribution setup. Its knowledge allows medical practitioners to provide sophisticated solutions for a wide range such as wrinkle reduction, hair removal and body contouring. It faces some competition from Cutera among others.