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FDA issues 510(k) clearance for Varilite dual wavelength laser.

Women's Health Weekly

| November 04, 2004 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2004 NOV 4 - (NewsRx.com & NewsRx.net) -- IRIDEX Corporation (IRIX) has received 510(k) clearance from the U.S. Food and Drug Administration for its new VariLite dual wavelength laser.

The VariLite was cleared for 19 specific dermatology indications including the treatment of vascular lesions, leg veins, benign pigmented lesions, cutaneous lesions, hair removal, and moderate inflammatory acne vulgaris.

Theodore A. Boutacoff, president and chief executive officer commented, "The VariLite laser increases IRIDEX' product offerings and indications amenable to treatment for dermatologists and plastic surgeons.

"It combines the benefits of our popular 532 nm DioLite laser system and a high power 940 nm laser system into a single platform. The VariLite satisfies physician demands for versatility and affordability, and we believe it will set a new standard for performance and value in the dermatology and plastic surgery markets."

The VariLite system features ergonomic dual wavelength handpieces that allow immediate switching between the two wavelengths for added convenience when treating a ...

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