FDA 510(k) Applications Submitted by Sofwave Medical Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K230019 01/03/2023 SofWave System Sofwave Medical Ltd.
K250146 01/21/2025 SofWave System Sofwave Medical Ltd.
K240687 03/12/2024 SofWave System Sofwave Medical Ltd.
K211483 05/12/2021 SofWave System Sofwave Medical Ltd.
K191421 05/28/2019 Sofacia System Sofwave Medical Ltd.
K251746 06/06/2025 Pure Impact Sofwave Medical Ltd.
K241685 06/11/2024 SofWave System Sofwave Medical Ltd.
K232455 08/14/2023 SofWave System Sofwave Medical Ltd.
K233104 09/26/2023 SofWave System Sofwave Medical Ltd.
K223237 10/19/2022 SofWave System Sofwave Medical Ltd.
K231537 05/30/2023 SofWave System Sofwave Medical Ltd.


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