IRIDEX Corporation
MOUNTAIN VIEW, Calif., Aug. 15 /PRNewswire-FirstCall/ -- IRIDEX
Corporation (Nasdaq:
IRIX -
News) 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.