Class Class II
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (K230597)
Description
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) by Light Tree Ventures Europe B.V., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230597
Clearance Date2023-04-28
Clearance TypeTraditional
Product CodeOAP
Regulation Number890.5500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230597
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. Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (K230597) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230579 | Smart Wedge algorithm | Edwards Lifesciences, LLC | 2023 |
| K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021 |
Trace the full predicate network for K230597
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.