Focal One®
FDA 510(k) clearance K251910 · decided 2025-11-19
Clearance details
- K-number
- K251910
- Device name
- Focal One®
- Applicant
- Edap Technomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-20
- Decision date
- 2025-11-19
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- PLP
- Device class
- 2
- Regulation number
- 876.4340
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edap Technomed
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.