Class Class II
OcuMet Beacon (OCUB100) (K241931)
Description
OcuMet Beacon (OCUB100) by Ocusciences, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241931
Clearance Date2025-04-22
Clearance TypeTraditional
Product CodeMYC
Regulation Number886.1570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241931
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OcuMet Beacon (OCUB100) (K241931) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | 2021 |
| K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020 |
Trace the full predicate network for K241931
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.