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Iridex Gets FDA Clearance for IQ Laser Systems
(Wireless News Via Acquire Media NewsEdge)
Iridex announced 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, MicroPulse or LongPulse 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.
Theodore A. Boutacoff, President and CEO, said, "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, 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."
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.
((Comments on this story may be sent to newsdesk@closeupmedia.com))
((Distributed on behalf of 10Meters via M2 Communications Ltd -
http://www.m2.com))
((10Meters - http://www.10meters.com))
Copyright ? 2008 Wireless News
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