MOUNTAIN VIEW, Calif., Oct. 7 /PRNewswire-FirstCall/ -- IRIDEX Corporation (Nasdaq: IRIX) announced today that it has received 510(k) clearance from the Food & Drug Administration (FDA) 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, making it one of the most versatile semiconductor-based laser systems on the market. The VariLite offers 532 nm and 940 nm wavelengths in a small, reliable, affordable and convenient platform.
Theodore A. Boutacoff, President and CEO 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(TM) 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 wide variety of dermatological indications. The 532 nm wavelength is the standard of care for purpura-free treatment of facial vessels and pigmented lesions and complements the 940 nm wavelength which penetrates more deeply into tissue allowing treatment of larger vessels, such as leg veins. Treatment usually takes just a few minutes and normally yields immediate outcomes without bruising, allowing patients to quickly resume normal activities with little risk of side effects.
"We believe the VariLite is well positioned for adoption by physicians looking for versatility in a first laser purchase, for those considering purchasing multiple competitive laser systems, and for those with existing IRIDEX products who are looking to upgrade to this new technology system to expand indications," Mr. Boutacoff continued.
IRIDEX will introduce the VariLite at the upcoming American Society of Plastic Surgery (ASPS) annual meeting being held October 9-12, 2004 in Philadelphia, PA, and internationally at the 13th Congress of the European Academy of Dermatology and Venereology (EADV) being held November 17-21, 2004 in Florence, Italy.
About IRIDEX
IRIDEX Corporation is a leading worldwide provider of semiconductor-based laser systems for the ophthalmology and dermatology markets. IRIDEX products are sold in the United States through a direct sales force and internationally through a network of independent distributors into more than 100 countries. For further information, visit the Company's website at www.iridex.com or call 650-962-8100.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Act of 1934, as amended, relating to the VariLite lasers satisfying physicians demand for versatility and affordability and setting new standards for performance and value. These statements are subject to risks and uncertainties and actual results could differ materially from those projected in the forward-looking statements based on, among other things, market acceptance and perception of the physician regarding the versatility, affordability, performance and value of the VariLite lasers and the competitive offerings facing the VariLite lasers. For additional risks that may affect these results, please see the risks contained in our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K for the fiscal year ended January 3, 2004 filed with the Securities and Exchange Commission. Forward- looking statements contained in this announcement are made as of this date and will not be updated.
SOURCE IRIDEX Corporation
-0- 10/07/2004
/CONTACT: Larry Tannenbaum, Chief Financial Officer of IRIDEX
Corporation, +1-650-940-4700/
/Web site: http://www.iridex.com /
(IRIX)
CO: IRIDEX Corporation
ST: California, Italy, Pennsylvania
IN: CPR SEM PEL HEA MTC
SU: PDT TDS
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