K251910
- 510(k) number
- K251910
- Device name
- Focal One®
- Applicant
- Edap Technomed, Inc. TX · US
- Product code
- PLP — High Intensity Ultrasound System For Prostate Tissue
- Decision date
- 2025-11-19
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251910.pdf
Official FDA record: K251910
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.