Aug 15 2008
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."