510(k) K251910
- Device
- Focal One®
- Applicant
- Edap Technomed, Inc.
- 510(k) number
- K251910
- Product code
- PLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-19
- Date received
- 2025-06-20
- Regulation
- 876.4340
- Classification name
- High Intensity Ultrasound System For Prostate Tissue Ablation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hugo Embert
- Address
- 5321 Industrial Oaks Blvd. Suite 110 Austin TX US 78735 78735
FDA Registration Numbers#
- 2951226
- 3012604011
- 1450662
- 9615058
- 3007126306
- 9612448
- 1287394
Source Documents#
Other 510(k) Records For Product Code PLP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | 2024-05-09 |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. | 2023-10-30 |
| K230692 | TULSA-PRO System | Profound Medical, Inc. | 2023-09-20 |
| K211858 | TULSA-PRO System | Profound Medical, Inc. | 2022-09-06 |
| K212150 | Exablate Prostate System | Insightec, Inc. | 2021-11-23 |
| K202286 | Tulsa-Pro System | Profound Medical, Inc. | 2020-09-16 |
| K191200 | TULSA-PRO System | Profound Medical, Inc. | 2019-08-15 |
| K172721 | FOCAL ONE | Edap Technomed, Inc. | 2018-06-07 |
| K172285 | Ablatherm Fusion | Edap Technomed, Inc. | 2017-10-03 |
| K160942 | Sonablate | Sonacare Medical, LLC | 2016-12-21 |
| K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015-11-06 |
| DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015-10-09 |