FDA clears Iridex's IQ Laser Systems for ophthalmology, ENT/otolaryngology, dermatology

Aug. 18, 2008

August 18, 2008 -- Iridex Corp. (Mountain View, CA) has received FDA 510(k) clearance for its line of IQ Laser Systems designed for applications in ophthalmology, ear, nose and throat (ENT)/otolaryngology, and dermatology. The IQ design concept enables different solid-state lasers based on a common platform; the first to be released will deliver 577 nm yellow light, providing "a wavelength and technology. . . not commercially available from any of our competitors," the company says.

August 18, 2008 -- Iridex Corporation (Mountain View, CA; Nasdaq: IRIX) says it has received FDA 510(k) clearance for its line of Iridex IQ Laser Systems designed for specific applications in ophthalmology, ear, nose and throat (ENT)/otolaryngology, and dermatology. This clearance covers the Iridex IQ 532 (green laser), IQ 577 (yellow), IQ 630-670 (red), and IQ 810 (infrared) laser products and their associated delivery devices to deliver laser energy in either CW-Pulse, MicroPulse or LongPulse mode.

"The design concept of the IQ Family enables us to provide different solid-state lasers on a common platform," said Iridex president and CEO Mr. Theodore A. Boutacoff. "We expect this common platform concept to facilitate the efficient development and timely introduction of related products."

The company says its first product to be released using this platform is the IQ 577, 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," said Boutacoff. "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."

Iridex describes its trademarked MicroPulse mode as 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.