K231628
- 510(k) number
- K231628
- Device name
- BeShape One Device
- Applicant
- Beshape Technologies , Ltd. IL
- Product code
- OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cel
- Decision date
- 2023-09-29
- Date received
- 2023-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231628.pdf
Official FDA record: K231628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.