MOUNTAIN VIEW, Calif., Oct. 13 /PRNewswire-FirstCall/ -- IRIDEX Corporation (Nasdaq: IRIX) announced 510(k) clearance from the Food & Drug Administration (FDA) for the new solid-state IRIS Medical IQ 810 infrared diode laser photocoagulator for the treatment of retinal disorders and glaucoma. The Company's top-of-the-line, solid-state system represents its latest technological innovation and is designed to perform traditional and Minimum Intensity Photocoagulation(TM) (MIP) procedures in the office and operating room settings. In addition, the IQ 810 increases the clinical versatility available to ophthalmologists today with its SmartWare(TM) interactive software with customizable settings, advanced waveform capability, and unique FiberCheck(TM) Slit Lamp Adapter delivery device.
Theodore A. Boutacoff, President and CEO commented, "IRIDEX has been a pioneer and leader in the ophthalmic semiconductor-based laser industry since 1989 when the OcuLight(R) product line was first introduced. Now, we are pleased to introduce the IQ 810, an intelligently engineered laser system designed to expand treatment capability to ophthalmologists while also simplifying use for MIP procedures."
The IQ 810 features SmartWare interactive software for intuitive set up and operation of the laser, customization of laser output and settings, and integrated system diagnostics. SmartWare enables quick access to CW-Pulse(TM) (continuous wave), MicroPulse(TM), and LongPulse(TM) operating modes as well as advanced pulse modalities, Group and PowerStep(TM), for precise control and laser energy output customization with developing protocols.
The IQ 810 is lightweight and portable, facilitating easy transport of the device from room-to-room or clinic-to-clinic. The intelligently designed internal circuitry results in precise pulse timing, power stability and consistent laser mode quality.
The IQ 810 is compatible with a variety of IRIS Medical delivery devices including the FiberCheck Slit Lamp Adapter (SLA), Laser Indirect Ophthalmoscope, G-Probe(TM), DioPexy(TM) Probe and family of EndoProbe(R) handpieces to maximize clinical versatility. The FiberCheck feature for the SLA is unique and new to the IQ 810 and allows the doctor to quickly and easily verify the integrity of the fiber before treatment which is increasingly important with the adoption of MIP procedures where endpoints are not visible.
The IQ 810 will be featured at the IRIDEX exhibit during the 2004 annual meeting of the American Academy of Ophthalmology (AAO) being held in New Orleans, October 22-26, 2004. The IQ 810 has been released to the market and is currently available to ship.
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 Company's anticipated shipments of its IRIS Medical IQ 810 and the long term reliability of the IQ 810 product. 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, the scale-up of manufacturing of the IQ 810 product, market acceptance and customer demand for this product and customer use and experience with the reliability of this product in actual high volume use in the field, risks inherent in clinical trial process, including the timing and nature of results from such trials. 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- 10/13/2004
/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, Louisiana
IN: CPR SEM HEA MTC
SU: TDS
RN-MW
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5761 10/13/2004 07:01 EDT http://www.prnewswire.com
