# Inmode MD, Ltd.

- Location (FDA's records): Yokneam, IL
- FDA decisions: 21 (2013–2021): 21 510(k) clearances
- Product codes: GEI (9), GEX (5), PBX (5), ONF (1), NUV (1)
- 510(k) review time since 2016: median 131 days, against 108 for FDA's reviews in the same codes and years (6 of 16 faster)
- Predicates its devices cite: 27 (11 its own); citations of its devices by later devices: 39 (11 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
- Viora, Ltd.: 2 (https://510kreport.com/company/viora)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Endymed Medical, Ltd.: 2 (https://510kreport.com/company/endymed-medical)
- Quantel Derma GmbH: 2 (https://510kreport.com/company/quantel-derma)
- Sciton, Inc: 1 (https://510kreport.com/company/sciton)
- Asclepion Laser Technologies GmbH: 1 (https://510kreport.com/company/asclepion-laser-technologies)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)
- Thermigen, Inc.: 1 (https://510kreport.com/company/thermigen)

## Firms that cite its devices most
- InMode, Ltd.: 18 (https://510kreport.com/company/inmode)
- El Global Trade, Ltd.: 3 (https://510kreport.com/company/el-global-trade)
- Weero Co., Ltd.: 2 (https://510kreport.com/company/weero)
- High Technology Products S.L.U: 1 (https://510kreport.com/company/high-technology-products-slu)
- Inbella Medical, Inc.: 1 (https://510kreport.com/company/inbella-medical)
- Indiba S. A. U.: 1 (https://510kreport.com/company/indiba-s-a-u)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)
- Sanhe Lefis Electronics Co., Ltd.: 1 (https://510kreport.com/company/sanhe-lefis-electronics)

## Its most-cited devices
- K210492: InMode RF Pro System (2021), cited by 4
- K180189: InMode System with Fractora3D/3D-90 Applicators (2018), cited by 4
- K180719: InMode Diolaze System (2018), cited by 3
- K131362: Inmode Wmbody Device (2013), cited by 3
- K160329: InMode System MiniFX Handpiece (2016), cited by 3
- K153568: InMode Plus System (2016), cited by 3

## Recent decisions
- K210492: InMode RF Pro System (Jul 12, 2021)
- K192695: InMode System with the Morpheus8 (Fractora) Applicators (Dec 27, 2019)
- K191855: EmFace Device (Oct 29, 2019)
- K183450: EmBody System (Jun 20, 2019)
- K182325: InMode RF System (Sep 26, 2018)
- K180719: InMode Diolaze System (Jun 14, 2018)
- K180189: InMode System with Fractora3D/3D-90 Applicators (Jun 1, 2018)
- K173677: InMode VLaze (Feb 23, 2018)

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