FDA 510(k) Applications Submitted by AMIT GOREN

FDA 510(k) Number Submission Date Device Name Applicant
K230013 01/03/2023 Silk'n Titan Allways Silk'n Beauty Ltd.
K180189 01/23/2018 InMode System with Fractora3D/3D-90 Applicators Inmode MD Ltd.
K160195 01/27/2016 Forma System, Forma Light System FORMATK SYSTEMS LTD.
K180279 01/31/2018 Silk'n MODEL H5003 device Home Skinovations Ltd.
K160329 02/05/2016 InMode System MiniFX Handpiece InMode MD Ltd.
K200293 02/05/2020 InMode System with vTone Applicator InMode Ltd.
K210492 02/19/2021 InMode RF Pro System InMode MD Ltd.
K170738 03/10/2017 InMode Diolaze XL InMode MD Ltd.
K180719 03/19/2018 InMode Diolaze System InMode MD Ltd.
K210877 03/24/2021 Evolve System with the T3 Applicator InMode Ltd.
K200947 04/08/2020 InMode System with the Morhpeus8 Applicators InMode Ltd.
K201150 04/29/2020 InMode RF Multi-System InMode Ltd.
K201285 05/13/2020 InMode Evolve System with the Tone Applicator InMode Ltd.
K171433 05/15/2017 Silk'n Infinity Home Skinovations Ltd.
K171593 05/31/2017 InMode RF System InMode MD Ltd.
K221571 05/31/2022 InMode Multi-system InMode Ltd.
K231628 06/05/2023 BeShape OneÖ Device BeShape Technologies Ltd.
K212107 07/06/2021 Reverso Intelis Instruments Ltd.
K191855 07/10/2019 EmFace Device InMode MD Ltd.
K172302 07/31/2017 InMode PLUS System InMode MD Ltd.
K192249 08/19/2019 InMode System with Tone Applicator InMode Ltd.
DEN190039 08/22/2019 ToothWaveÖ Home Skinovations Ltd.
K182325 08/27/2018 InMode RF System Inmode MD Ltd.
K192695 09/26/2019 InMode System with the Morpheus8 (Fractora) Applicators Inmode MD Ltd.
K162784 10/03/2016 Silk'n HST Home Skinovations Ltd.
K163190 11/14/2016 InMode RF System INMODE MD LTD.
K183307 11/28/2018 Magma Spark Pro (Magma Spark Plus, Alpha) Formatk Systems Ltd.
K173677 11/30/2017 InMode VLaze InMode MD Ltd.
K183450 12/12/2018 EmBody System InMode MD Ltd.
K214078 12/27/2021 SilkÆn Toothwave Home Skinovations Ltd.


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