Inmode Ltd.
Yokneam Northern, IL
INMODE LTD. appears in FDA device records in Yokneam Northern, IL. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Inmode Ltd. between 2019 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251254 | Ignite RF System | GEI | Substantially Equivalent | |
| K251632 | Optimas MAX System | GEX | Substantially Equivalent | |
| K242598 | DEFINE System (AG612444A) | PBX | Substantially Equivalent | |
| K240780 | InMode RF System | GEI | Substantially Equivalent | |
| K240017 | InMode System with the Morpheus8 90 Applicator | GEI | Substantially Equivalent | |
| K233642 | InMode RF System | GEI | Substantially Equivalent | |
| K231495 | The Evolve System with the Transform Applicator | GEI | Substantially Equivalent | |
| K231790 | The InMode System with the Morpheus8 Applicators | GEI | Substantially Equivalent | |
| K221571 | InMode Multi-system | GEX | Substantially Equivalent | |
| K210877 | Evolve System with the T3 Applicator | PBX | Substantially Equivalent | |
| K201285 | InMode Evolve System with the Tone Applicator | IPF | Substantially Equivalent | |
| K201150 | InMode RF Multi-System | GEI | Substantially Equivalent | |
| K200947 | InMode System with the Morhpeus8 Applicators | GEI | Substantially Equivalent | |
| K200293 | InMode System with vTone Applicator | KPI | Substantially Equivalent | |
| K192249 | InMode System with Tone Applicator | IPF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010511300 | 3010511300 | INMODE LTD. | Tavor Building (POB 533), Yokneam Northern 2069206 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ISAMassager, Therapeutic, Electric
- NUVMassager, Vacuum, Light Induced Heating
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- GEXPowered Laser Surgical Instrument
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- KXQVibrator For Therapeutic Use, Genital
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain