K243716
- 510(k) number
- K243716
- Device name
- Zionic Pro Max (Radiofrequency)
- Applicant
- Termosalud S.L. ES
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2025-05-28
- Date received
- 2024-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243716.pdf
Official FDA record: K243716
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.