Inmode MD, Ltd.
Kfar Saba, IL
Inmode MD , Ltd. appears in FDA device records in Kfar Saba, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Inmode MD, Ltd. between 2013 and 2021. The busiest year on record is 2016, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 3 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210492 | InMode RF Pro System | GEI | Substantially Equivalent | |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | GEI | Substantially Equivalent | |
| K191855 | EmFace Device | PBX | Substantially Equivalent | |
| K183450 | EmBody System | PBX | Substantially Equivalent | |
| K182325 | InMode RF System | GEI | Substantially Equivalent | |
| K180719 | InMode Diolaze System | GEX | Substantially Equivalent | |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | GEI | Substantially Equivalent | |
| K173677 | InMode VLaze | GEX | Substantially Equivalent | |
| K172302 | InMode PLUS System | PBX | Substantially Equivalent | |
| K171593 | InMode RF System | GEI | Substantially Equivalent | |
| K170738 | InMode Diolaze XL | GEX | Substantially Equivalent | |
| K163190 | InMode RF System | GEI | Substantially Equivalent | |
| K160329 | InMode System MiniFX Handpiece | PBX | Substantially Equivalent | |
| K153568 | InMode Plus System | PBX | Substantially Equivalent | |
| K151793 | InMode RF System | GEI | Substantially Equivalent | |
| K151273 | InMode FRF Applicator | GEI | Substantially Equivalent | |
| K142952 | InMode Diolaze Device | GEX | Substantially Equivalent | |
| K140926 | INMODE WMFACE DEVICE | GEI | Substantially Equivalent | |
| K131362 | INMODE WMBODY DEVICE | NUV | Substantially Equivalent | |
| K123860 | INMODE SR IPL DEVICE | ONF | Substantially Equivalent | |
| K123682 | INMODE HAIR REMOVAL (HR) DEVICE | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain