Iridex wins FDA 510(k) for TruFocus LIO premiere ophthalmological laser

Iridex (NSDQ:IRIX) said yesterday it won FDA 510(k) clearance for its TruFocus LIO premiere ophthalmological laser accessory and that it launched the device in the US.

The TruFocus LIO Premiere is a light combination and reflection viewing system designed to be used with the Iridex retina laser system, the Mountain View, Calif.-based company said.

The newly cleared device is designed to be worn on the physician’s head and combines a laser treatment beam with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam which can be used with a handheld examination lens to view and treat a patient’s retina, Iridex said.

“We are pleased to again be offering our full portfolio of laser delivery devices to doctors in the U.S. We would like to thank our team and the FDA for their diligent attention to this matter,” prez & CEO William Moore said in a press release.

In July, Navigated retinal laser system developer OD-OS said that it won a European patent spat with Iridex related to ophthalmological laser systems.

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