VISUREF 600

VISUREF 600 is a combined autorefractor and keratometer device designed to measure the refractive power and corneal curvature of the human eye. It supports anterior eye segment examination including assessment of lens opacity via retro-illumination, measurement of tear film break-up time, and imaging of meibomian glands using infrared illumination. The device is intended for pre- and post-examination of the human eye by ophthalmologists, optometrists, opticians, and technicians.

The main technological difference from the predicate (SL 220) is the visualization method: VISUREF 600 uses a built-in high-resolution camera with integrated display, while SL 220 uses a stereomicroscope with eyepiece. Both devices employ LED illumination for direct and retro-illumination examination. VISUREF 600 has a maximum power consumption of 150 VA and operates at 100–240 V AC, 50–60 Hz. Both devices are Group 2 light hazard protection devices and conform to equivalent safety standards despite different wavelengths used.

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021], ANSI Z80.36-2021, IEC 60825-1:2014, ISO 10993-1:2018 for biocompatibility (cytotoxicity, sensitization, irritation), and ANSI/AAMI 62304:2006/A1:2016 for software development. Both predicate and subject devices were tested for light emission and comply with Group 2 limits.

VISUREF 600 is substantially equivalent to the predicate device SL 220 because both are designed to visualize the anterior eye segment using LED illumination and perform equivalent examination techniques including lens opacity assessment, tear film break-up time measurement, and meibomian gland imaging. Both devices operate within equivalent light emission safety parameters, serve the same intended users and indications for use, and the technological difference in visualization method (built-in camera versus eyepiece observation) does not raise new safety or effectiveness questions. Non-clinical performance testing confirms VISUREF 600 meets the same standards and is as safe and effective as the predicate device.