Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

InMode , Ltd.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories5
Latest FDA decision2026-01-15
TypeNumberDevice NameCodeDateActions
510(k) K251254 Ignite RF SystemGEI2026-01-15 View
510(k) K251632 Optimas MAX SystemGEX2025-06-26 View
510(k) K242598 DEFINE System (AG612444A)PBX2024-11-14 View
510(k) K240780 InMode RF SystemGEI2024-07-24 View
510(k) K240017 InMode System with the Morpheus8 90 ApplicatorGEI2024-06-13 View
510(k) K233642 InMode RF SystemGEI2024-03-20 View
510(k) K231495 The Evolve System with the Transform ApplicatorGEI2023-10-13 View
510(k) K231790 The InMode System with the Morpheus8 ApplicatorsGEI2023-07-20 View
510(k) K221571 InMode Multi-systemGEX2022-06-30 View
510(k) K210877 Evolve System with the T3 ApplicatorPBX2021-07-19 View
510(k) K201285 InMode Evolve System with the Tone ApplicatorIPF2021-03-05 View
510(k) K201150 InMode RF Multi-SystemGEI2020-07-22 View
510(k) K200947 InMode System with the Morhpeus8 ApplicatorsGEI2020-07-02 View
510(k) K200293 InMode System with vTone ApplicatorKPI2020-05-05 View
510(k) K192249 InMode System with Tone ApplicatorIPF2019-12-17 View
↑