Iridex Announces FDA Clearance of Updated TruFocus LIO Premiere Laser Accessory

Source: Iridex

Iridex announced the introduction of its updated TruFocus LIO Premiere laser accessory following FDA 510(k) clearance.  

The TruFocus LIO Premiere is a light combination and reflection viewing system used with Iridex retina laser systems and is worn on the physician’s head. The product combines a laser treatment beam from an Iridex laser source with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination lens to enter a patient’s pupil and to view and treat a patient’s retina. It provides a portable alternative to patients who cannot be examined or treated with a fixed slit lamp adapter. The device can be used to evaluate and treat patients of all ages, including infants, in an office, operating room, and ambulatory surgical center setting.

“We are pleased to again be offering our full portfolio of laser delivery devices to doctors in the U.S.,” William M. Moore, President and Chief Executive Officer, said in a company news release. “We would like to thank our team and the FDA for their diligent attention to this matter.”

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