# InMode, Ltd.

- Location (FDA's records): Yokneam, IL
- FDA decisions: 15 (2019–2026): 15 510(k) clearances
- Product codes: GEI (8), PBX (2), IPF (2), GEX (2), KPI (1)
- 510(k) review time since 2016: median 119 days, against 125 for FDA's reviews in the same codes and years (8 of 14 faster)
- Predicates its devices cite: 35 (12 its own); citations of its devices by later devices: 29 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Inmode MD, Ltd.: 18 (https://510kreport.com/company/inmode-md)
- Ne Services, Ltd.: 1 (https://510kreport.com/company/ne-services)
- Invasix, Ltd.: 1 (https://510kreport.com/company/invasix)
- Djo, LLC: 1 (https://510kreport.com/company/djo)
- Btl: 1 (https://510kreport.com/company/btl)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)

## Firms that cite its devices most
- Inbella Medical, Inc.: 6 (https://510kreport.com/company/inbella-medical)
- Weero Co., Ltd.: 5 (https://510kreport.com/company/weero)
- Swims America Corp: 2 (https://510kreport.com/company/swims-america)
- El.En Electronic Engineering Spa: 1 (https://510kreport.com/company/el-en-electronic-engineering)
- Inmode MD, Ltd.: 1 (https://510kreport.com/company/inmode-md)
- Pollogen, Ltd.: 1 (https://510kreport.com/company/pollogen)
- Cynosure Lutronic Technology Corporation: 1 (https://510kreport.com/company/cynosure-lutronic-technology)

## Its most-cited devices
- K231790: The InMode System with the Morpheus8 Applicators (2023), cited by 7
- K210877: Evolve System with the T3 Applicator (2021), cited by 5
- K200947: InMode System with the Morhpeus8 Applicators (2020), cited by 4
- K240780: InMode RF System (2024), cited by 3
- K201285: InMode Evolve System with the Tone Applicator (2021), cited by 3
- K192249: InMode System with Tone Applicator (2019), cited by 2

## Recent decisions
- K251254: Ignite RF System (Jan 15, 2026)
- K251632: Optimas MAX System (Jun 26, 2025)
- K242598: DEFINE System (AG612444A) (Nov 14, 2024)
- K240780: InMode RF System (Jul 24, 2024)
- K240017: InMode System with the Morpheus8 90 Applicator (Jun 13, 2024)
- K233642: InMode RF System (Mar 20, 2024)
- K231495: The Evolve System with the Transform Applicator (Oct 13, 2023)
- K231790: The InMode System with the Morpheus8 Applicators (Jul 20, 2023)

Source page: https://510kreport.com/company/inmode