K250718
- 510(k) number
- K250718
- Device name
- swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- Applicant
- Emblation Limited GB
- Product code
- NEY — System, Ablation, Microwave And Accessories
- Decision date
- 2025-08-08
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K250718.pdf
Official FDA record: K250718
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.