FDAnews Device Daily Bulletin

Iridex Receives FDA Clearance for New Family of Laser Systems

Aug. 18, 2008

The FDA has granted 510(k) clearance for Iridex’s family of IQ laser systems.

The IQ 532, IQ 577, IQ 630-670 and IQ 810 systems and their associated delivery devices can now be used in ophthalmology, ear, nose, throat, otolaryngology and dermatology applications.

The systems deliver laser energy in CW-Pulse, MicroPulse or LongPulse modes. The company said it will launch the IQ 577 first as it provides a wavelength not available in laser systems already on the market.