K251910 is an FDA 510(k) clearance for the Focal One®. This device is classified as a High Intensity Ultrasound System For Prostate Tissue Ablation (Class II - Special Controls, product code PLP).
Submitted by Edap Technomed, Inc. (Austin, US). The FDA issued a Cleared decision on November 19, 2025, 152 days after receiving the submission on June 20, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4340. Prostate Tissue Ablation.
| 510(k) Number | K251910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2025 |
| Decision Date | November 19, 2025 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PLP - High Intensity Ultrasound System For Prostate Tissue Ablation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4340 |
| Definition | Prostate Tissue Ablation |