OcuMet Beacon (OCUB100)

The OcuMet Beacon is a confocal scanning ophthalmoscope that uses infrared (IR) and blue light to acquire non-invasive black-and-white reflectance and autofluorescence images of the human retina. It integrates a tablet interface with a dedicated software application and operates as a standalone device, with clinical interpretation restricted to licensed eye care practitioners.

The device uses LED-based illumination (IR at 850 nm and blue LED at 460–475 nm with a 520–540 nm detection filter) to perform confocal line scanning. It has reduced field of view (IR 60° × 21.5°; AF 17° × 21.5°) compared to the predicate EIDON AF, but achieves similar imaging modalities through multiple acquisitions. It meets Group 1 light safety under ANSI Z80.36-2016 with 60 W power consumption at 12 VDC.

IEC 60601-1 (electrical safety); IEC 60601-1-2 (EMC); ANSI Z80.36-2016 (light hazard classification); ISO 15004-2:2007 (ophthalmic instruments light safety); biocompatibility testing requirements for patient contact points.

The OcuMet Beacon uses the same confocal LED scanning technology and imaging modalities (IR and AF) as the predicate EIDON AF device, with identical intended use for retinal imaging with or without mydriasis. Although the OcuMet has narrower field of view and LED excitation versus the predicate's broader spectrum, it achieves equivalent clinical performance through multiple image acquisitions. Both devices comply with the same electrical safety and light hazard standards, have comparable dimensions, weight, and power consumption, and pose no new safety risks.