FDAnews Device Daily Bulletin

FDA APPROVES CANDELA'S ELLIPSE FLEX IPL INTENSE PULSED LIGHT SYSTEM

Dec. 27, 2005
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The FDA has approved Candela's Ellipse Flex IPL device, a flexible intense pulsed light system that treats cosmetic conditions including facial rejuvenation, vascular lesions, facial veins, acne, age spots and diffuse redness.

The Ellipse Flex features a programmable pulse mode that lets clinicians design the output pulse of the device to fit almost any clinical situation presented. This allows the user to customize the treatment settings to each specific patient, enabling a more personalized treatment session.

The product was developed in cooperation with leading skin researchers and dermatologists, Candela said. "Adding the Flex IPL system to our product line demonstrates our commitment to continue to offer the widest range of laser and light based products and technology solutions to our customers," said Gerard Puorro, president and CEO of Candela.

The programmable pulse mode lets clinicians fine-tune treatment settings to a degree not possible with other IPL systems, said Michael Drosner, a dermatologist at the Cutaris Center in Munich, Germany. "This allows me to create a treatment profile that is specific for each patient," he said. "The patient's profile is easily saved for the patient's next visit, making each treatment experience consistent."

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