Class Class II
VISULAS combi (K233911)
Description
VISULAS combi by Carl Zeiss Meditec, AG, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233911
Clearance Date2024-09-06
Clearance TypeTraditional
Product CodeHQF
Regulation Number886.4390
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233911
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. VISULAS combi (K233911) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232051 | VISULAS green | Carl Zeiss Meditec | 2023 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023 |
Trace the full predicate network for K233911
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.