K240687
- 510(k) number
- K240687
- Device name
- SofWave System
- Applicant
- Sofwave Medical, Ltd. IL
- Product code
- OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cel
- Decision date
- 2024-05-30
- Date received
- 2024-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240687.pdf
Official FDA record: K240687
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.