Inmode MD , Ltd.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Inmode MD , Ltd.” (first 2013, latest 2021), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 130 days. Since 2017 the median was 129 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 3 | 109 |
| 2014 | 1 | 236 |
| 2015 | 1 | 95 |
| 2016 | 5 | 211 |
| 2017 | 3 | 132 |
| 2018 | 4 | 86 |
| 2019 | 3 | 111 |
| 2020 | 0 | — |
| 2021 | 1 | 143 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inmode MD , Ltd. took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 9 |
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 | 5 |
| NUV | Massager, Vacuum, Light Induced Heating | 1 | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
Review panels
Most recent Inmode MD , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210492 | InMode RF Pro System | GEI | 2021-07-12 | 143 |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | GEI | 2019-12-27 | 92 |
| K191855 | EmFace Device | PBX | 2019-10-29 | 111 |
| K183450 | EmBody System | PBX | 2019-06-20 | 190 |
| K182325 | InMode RF System | GEI | 2018-09-26 | 30 |
| K180719 | InMode Diolaze System | GEX | 2018-06-14 | 87 |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | GEI | 2018-06-01 | 129 |
| K173677 | InMode VLaze | GEX | 2018-02-23 | 85 |
| K172302 | InMode PLUS System | PBX | 2017-12-08 | 130 |
| K171593 | InMode RF System | GEI | 2017-10-10 | 132 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Inmode MD , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Inmode MD , Ltd. is the lead sponsor of 22 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07209397: Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women (Recruiting, started 2025-11-25)
- NCT06283498: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder (Enrolling by invitation, started 2023-11-10)
- NCT06458556: Transvaginal Radiofrequency Ablation for Overactive Bladder (Completed, started 2023-06-19)
- NCT06283056: RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite (Completed, started 2022-06-16)
- NCT05398172: Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy (Completed, started 2021-08-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- InMode , Ltd. (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inmode MD , Ltd.?
FDA lists 21 510(k) clearances under the applicant name “Inmode MD , Ltd.” (first 2013, latest 2021), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Inmode MD , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inmode MD , Ltd. is 130 days. Since 2017: 129 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inmode MD , Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9); GEX (Powered Laser Surgical Instrument, 5); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 5).
Next steps
- See all 21 Inmode MD , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Inmode MD , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.