FDA 510(k) Applications for Medical Device Product Code "PLP"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K172285 | EDAP TECHNOMED, INC. | Ablatherm Fusion | 10/03/2017 |
| K153023 | EDAP TECHNOMED, INC. | Ablatherm Integrated Imaging | 11/06/2015 |
| K172721 | EDAP Technomed, Inc. | FOCAL ONE | 06/07/2018 |
| K212150 | Insightec, Inc | Exablate Prostate System | 11/23/2021 |
| K231378 | Insightec, Ltd. | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | 10/30/2023 |
| K202286 | Profound Medical Inc | Tulsa-Pro System | 09/16/2020 |
| K211858 | Profound Medical Inc. | TULSA-PRO System | 09/06/2022 |
| K191200 | PROFOUND MEDICAL INC. | TULSA-PRO System | 08/15/2019 |
| K230692 | Profound Medical Inc. | TULSA-PRO System | 09/20/2023 |
| K240296 | Profound Medical, Inc. | Tulsa Pro System (Pad-105) | 05/09/2024 |
| K160942 | SonaCare Medical, LLC | Sonablate | 12/21/2016 |
| DEN150011 | SonaCare Medical, LLC. | Sonablate 450 | 10/09/2015 |
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