FDA 510(k) Applications Submitted by Ruthie Amir

FDA 510(k) Number Submission Date Device Name Applicant
K230019 01/03/2023 SofWave System Sofwave Medical Ltd.
K170370 02/06/2017 ULTRASHAPE POWER SYSTEM Syneron Medical Ltd.
K150326 02/09/2015 PicoWay Laser System Candela Corporation
K170597 02/28/2017 PicoWay Laser System Syneron Candela Corporation
K160607 03/02/2016 PicoWay Laser System SYNERON CANDELA CORPORATION
K230820 03/24/2023 SofWave System Sofwave Medical Ltd
K160896 03/31/2016 ULTRASHAPE POWER SYSTEM SYNERON MEDICAL LTD
K161043 04/13/2016 Profound System SYNERON CANDELA CORPORATION
K211483 05/12/2021 SofWave System Sofwave Medical Ltd.
K191421 05/28/2019 Sofacia System Sofwave Medical Ltd.
K151655 06/18/2015 CO2RE System SYNERON MEDICAL LTD.
K161952 07/15/2016 UltraShape System Syneron Medical Ltd.
K162163 08/02/2016 UltraShape System SYNERON MEDICAL LTD
K142372 08/25/2014 Pico Way Laser System CANDELA CORPATION
K162454 09/01/2016 PicoWay Laser System SYNERON CANDELA CORPORATION
K223237 10/19/2022 SofWave System Sofwave Medical Ltd.
K163415 12/05/2016 SlimShape System Syneron Medical Ltd.
K153527 12/09/2015 PicoWay Laser System SYNERON CANDELA CORPORATION
K231537 05/30/2023 SofWave System Sofwave Medical Ltd.


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