Class Class II
Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553)
Description
Tomey Cornea/Anterior Segment OCT (CASIA2) by Tomey Corporation, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250553
Clearance Date2025-07-18
Clearance TypeTraditional
Product CodeOBO
Regulation Number886.1570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250553
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. Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022 |
| K082891 | LENSTAR, MODEL LS900 | Haag-Streit AG | 2009 |
Trace the full predicate network for K250553
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.