510(k) K251910 · PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Focal One®
| Applicant | Edap Technomed, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Nov 19, 2025 |
| Received | Jun 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251910
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.