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# Iridex 510(k) for Laser Accessory Cleared
- URL: https://www.fdaweb.com/iridex-510-k-for-laser-accessory-cleared/
- Published: 2018-09-07T12:00:00.000Z
- Updated: 2026-09-15T00:30:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142299

FDA has cleared an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the 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,” the company says.