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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K180189

InMode System with Fractora3D/3D-90 Applicators · Inmode MD , Ltd. · decided 2018-06-01 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
InMode AG606991AINMODE M.D LTDGEX07290016633375
Morpheus8V ApplicatorAG609931AINMODE M.D LTDGEI07290016633696
FRACTORA 3D-90 TipAG607403AINMODE M.D LTDGEI07290016633719
Contoura - InMode RF™InMode RF™ - Black-BlueINMODE M.D LTDGEI PBX07290016633344