MOUNTAIN VIEW, Calif., Aug. 15 /PRNewswire-FirstCall/ -- IRIDEX Corporation announces receipt of FDA 510(k) clearance for its Family of IRIDEX IQ Laser Systems. This clearance covers the IRIDEX IQ 532, IQ 577, IQ 630-670, and IQ 810 Laser Systems and their associated delivery devices to deliver laser energy in either CW-Pulse(TM), MicroPulse(TM) or LongPulse(TM) mode. These Laser Systems are intended for a wide range of specific applications in the medical specialties of ophthalmology, ear, nose and throat (ENT)/otolaryngology and dermatology.
Mr. Theodore A. Boutacoff, President and CEO stated, “We are pleased to have passed this regulatory milestone. The design concept of the IQ Family enables us to provide different solid-state lasers on a common platform. This 510(k) covers green (532 nm), yellow (577 nm), red (630-670 nm), and infrared (810 nm) single wavelength systems. We expect this common platform concept to facilitate the efficient development and timely introduction of related products.
“The first product to be released to market using this platform will be the IQ 577(TM), which will deliver 577 nm yellow light from a solid-state laser in either conventional continuous wave (CW) or MicroPulse mode. The IQ 577 provides a wavelength and technology that complements our product portfolio and is not commercially available from any of our competitors. 577 nm is of interest because it is at the peak of the oxyhemoglobin absorption curve and was a popular wavelength when argon/dye laser systems were widely distributed -- however due to complexity and poor reliability those products are now obsolete. We believe that a reliable solid-state 577 nm laser system has the opportunity to fill this void.”
About MicroPulse Technology
MicroPulse mode can be viewed simply as a CW-Pulse that has been “chopped,” with brief LASER OFF intervals distributed uniformly over the CW-Pulse duration. The time interval between pulses provides time for the thermal energy to dissipate and slow the temperature elevation in the treated area. This offers the treating physician the opportunity for fine control of dose titration, which can result in a more tissue sparing laser application.
About IRIDEX
IRIDEX Corporation is a leading worldwide provider of therapeutic based laser systems, disposable laser probes and delivery devices to treat eye diseases in ophthalmology and skin disorders in the aesthetics market. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 100 independent distributors into 107 countries. For further information, visit the Company’s website at http://www.iridex.com.
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 Company’s market prospects and time to market for its Family of IRIDEX IQ Laser Systems. Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and our Quarterly Report on Form 10-Q for the second quarter ended June 28, 2008 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.
CONTACT: Jim Mackaness, Chief Financial Officer of IRIDEX Corporation,
+1-650-940-4700
Web site: http://www.iridex.com/
