Class Class II
Resolve Fundus Camera (K250683)
Description
Resolve Fundus Camera by Optain Health, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250683
Clearance Date2025-04-30
Clearance TypeTraditional
Product CodeHKI
Regulation Number886.1120
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250683
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. Resolve Fundus Camera (K250683) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180306 | Nexy | Next Sight Srl | 2018 |
Trace the full predicate network for K250683
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.