OcuMet Beacon (OCUB100)
OcuSciences, Inc.The OcuMet Beacon is a scanning LED-based ophthalmoscope that captures detailed black and white infrared and autofluorescence images of the human retina. It helps eye care clinicians by providing high-quality retinal images to assist in diagnosis and management of eye conditions, supporting clinical decisions as an adjunctive imaging modality.
Intended Use
OcuMet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent.
Technology
The device is a scanning LED based ophthalmoscope using infrared and blue light to obtain confocal images of the retina with multiple retinal fields captured by internal fixation target. It captures black and white reflectance and fluorescence images with dedicated analysis software. The device operates as a standalone unit integrating a tablet and external power supply.
Performance
Testing shows compliance with electrical safety, light hazard (Group 1 safety), biocompatibility, and system verification/validation. The device meets relevant IEC and ANSI standards and has performance comparable to predicate device EIDON AF and reference device Heidelberg Spectralis HRA+OCT.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/1/2024
9 months - 2
FDA Approval
4/22/2025
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