Class Class II
SPECTRALIS with Flex Module (K241163)
Description
SPECTRALIS with Flex Module by Heidelberg Engineering GmbH, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241163
Clearance Date2024-10-11
Clearance TypeTraditional
Product CodeOBO
Regulation Number886.1570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241163
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. SPECTRALIS with Flex Module (K241163) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023 |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | 2012 |
Trace the full predicate network for K241163
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.