IRIDEX has introduced its updated TruFocus LIO Premiere laser accessory, following US Food and Drug Administration (FDA) 510(k) review and clearance.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
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.
IRIDEX president and CEO William Moore 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.”
IRIDEX is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market.
The company’s proprietary MicroPulse technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions.
Source: Company Press Release.