Iridex, a provider of therapeutic based laser systems, has received US 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.
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."