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.
According to the company, 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 Boutacoff, president and CEO of Iridex, 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 (532nm), yellow (577nm), red (630-670nm), and infrared (810nm) single wavelength systems. We expect this common platform concept to facilitate the efficient development and timely introduction of related products.”