K232966
- 510(k) number
- K232966
- Device name
- FISIOWARM 7.0
- Applicant
- Golden Star Srl IT
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2024-12-26
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232966.pdf
Official FDA record: K232966
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.