Class Class II
Zionic Pro Max (Radiofrequency) (K243716)
Description
Zionic Pro Max (Radiofrequency) by Termosalud S.L., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243716
Clearance Date2025-05-28
Clearance TypeTraditional
Product CodePBX
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243716
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. Zionic Pro Max (Radiofrequency) (K243716) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230659 | Zionic Aesthetic | Termosalud | 2023 |
| K230412 | Symmed Elite Aesthetic | Termosalud | 2023 |
Trace the full predicate network for K243716
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.