PLP
13 FDA 510(k) clearances · Product code
152 daysmedian time to decision
272 days90th percentile
13clearances measured
FDA profile
- Official device name
- High Intensity Ultrasound System For Prostate Tissue Ablation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4340
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Prostate tissue ablation
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Focal One® (K251910) | Edap Technomed, Inc. | 2025-11-19 |
| Tulsa Pro System (Pad-105) (K240296) | Profound Medical, Inc. | 2024-05-09 |
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (K231378) | Insightec, Ltd. | 2023-10-30 |
| TULSA-PRO System (K230692) | Profound Medical, Inc. | 2023-09-20 |
| TULSA-PRO System (K211858) | Profound Medical, Inc. | 2022-09-06 |
| Exablate Prostate System (K212150) | Insightec, Inc. | 2021-11-23 |
| Tulsa-Pro System (K202286) | Profound Medical, Inc. | 2020-09-16 |
| TULSA-PRO System (K191200) | Profound Medical, Inc. | 2019-08-15 |
| FOCAL ONE (K172721) | Edap Technomed, Inc. | 2018-06-07 |
| Ablatherm Fusion (K172285) | Edap Technomed, Inc. | 2017-10-03 |
| Sonablate (K160942) | Sonacare Medical, LLC | 2016-12-21 |
| Ablatherm Integrated Imaging (K153023) | Edap Technomed, Inc. | 2015-11-06 |
| Sonablate 450 (DEN150011) | Sonacare Medical, LLC | 2015-10-09 |
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Every clearance here is in the API, with alerts when new ones post.