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510(k) Data Aggregation
K Number
K241931Device Name
OcuMet Beacon (OCUB100)
Manufacturer
OcuSciences, Inc.
Date Cleared
2025-04-22
(295 days)
Product Code
MYC
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
OcuSciences, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
Device Description
Ocumet Beacon is a scanning LED based ophthalmoscope which uses infrared and blue light to obtain confocal images of the retina. Multiple retinal fields can be captured using a programmable internal fixation target. The device integrates a tablet and is provided with an external power supply. The device works with a dedicated software application and operates as a standalone unit.
Ocumet Beacon offers two different acquisition modalities:
- black and white reflectance images of the retina obtained using infrared illumination;
- black and white fluorescence images of the retina obtained using blue illumination (peak at 458 nm) and a barrier filter to select only autofluorescent emission between 520 and 540 nm.
Clinician Report Generator Software is required to open, review, analyze, and print images obtained from Ocumet Beacon. The software runs on a standalone laptop.
The total light exposure is qualified as Group 1 under ANSI Z80.36-2016
Clinician Report Generator Software is required to open, review, analyze and print a co-registered version of both the infrared and visible wavelength images obtained from Ocumet Beacon. The software runs on a standalone Windows 10 or 11 based laptop computer.
The clinical interpretation of the images acquired by Ocumet Beacon is restricted to licensed eye care practitioners. A device specific training is required for any operator to become able to use the system and certification training is available for operators who will be capturing images in a clinical trial. The interpretation and use in clinical practice is as an adjunctive modality for the clinician to optionally combine with other structural images, and functional studies.
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