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Inmode , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251254Ignite RF SystemJanuary 15, 2026
K251632Optimas MAX SystemJune 26, 2025
K242598DEFINE System (AG612444A)November 14, 2024
K240780InMode RF SystemJuly 24, 2024
K240017InMode System with the Morpheus8 90 ApplicatorJune 13, 2024
K233642InMode RF SystemMarch 20, 2024
K231495The Evolve System with the Transform ApplicatorOctober 13, 2023
K231790The InMode System with the Morpheus8 ApplicatorsJuly 20, 2023
K221571InMode Multi-systemJune 30, 2022
K210877Evolve System with the T3 ApplicatorJuly 19, 2021
K201285InMode Evolve System with the Tone ApplicatorMarch 5, 2021
K201150InMode RF Multi-SystemJuly 22, 2020
K200947InMode System with the Morhpeus8 ApplicatorsJuly 2, 2020
K200293InMode System with vTone ApplicatorMay 5, 2020
K192249InMode System with Tone ApplicatorDecember 17, 2019