Medical Device Manufacturer · IL , Yokneam

Inmode , Ltd. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2019
15
Total
15
Cleared
0
Denied

Inmode , Ltd. has 15 FDA 510(k) cleared general & plastic surgery devices. Based in Yokneam, IL.

Latest FDA clearance: Jan 2026. Active since 2019.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Hogan Lovells US LLP and A. Stein - Regulatory Affairs Consulting , Ltd.. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Inmode , Ltd.
15 devices
1-15 of 15
Cleared Jan 15, 2026
Ignite RF System
K251254 · GEI
General & Plastic Surgery · 267d
Cleared Jun 26, 2025
Optimas MAX System
K251632 · GEX
General & Plastic Surgery · 29d
Cleared Nov 14, 2024
DEFINE System (AG612444A)
K242598 · PBX
General & Plastic Surgery · 76d
Cleared Jul 24, 2024
InMode RF System
K240780 · GEI
General & Plastic Surgery · 125d
Cleared Jun 13, 2024
InMode System with the Morpheus8 90 Applicator
K240017 · GEI
General & Plastic Surgery · 163d
Cleared Mar 20, 2024
InMode RF System
K233642 · GEI
General & Plastic Surgery · 128d
Cleared CT Oct 13, 2023
The Evolve System with the Transform Applicator
K231495 · GEI
General & Plastic Surgery · 143d
Cleared Jul 20, 2023
The InMode System with the Morpheus8 Applicators
K231790 · GEI
General & Plastic Surgery · 30d
Cleared Jun 30, 2022
InMode Multi-system
K221571 · GEX
General & Plastic Surgery · 30d
Cleared Jul 19, 2021
Evolve System with the T3 Applicator
K210877 · PBX
General & Plastic Surgery · 117d
Cleared Mar 05, 2021
InMode Evolve System with the Tone Applicator
K201285 · IPF
Physical Medicine · 296d
Cleared Jul 22, 2020
InMode RF Multi-System
K201150 · GEI
General & Plastic Surgery · 84d
Cleared Jul 02, 2020
InMode System with the Morhpeus8 Applicators
K200947 · GEI
General & Plastic Surgery · 85d
Cleared May 05, 2020
InMode System with vTone Applicator
K200293 · KPI
Gastroenterology & Urology · 90d
Cleared Dec 17, 2019
InMode System with Tone Applicator
K192249 · IPF
Physical Medicine · 120d
Filters