Class Class II
SofWave System (K230019)
Description
SofWave System by Sofwave Medical, Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230019
Clearance Date2023-03-14
Clearance TypeTraditional
Product CodeOHV
Regulation Number878.4590
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230019
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. SofWave System (K230019) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230820 | SofWave System | Sofwave Medical, Ltd. | 2023 |
Trace the full predicate network for K230019
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.