InMode , Ltd.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “InMode , Ltd.” (first 2019, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 117 days. Since 2017 the median was 117 days, against 106 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 |
|---|---|---|
| 2019 | 1 | 120 |
| 2020 | 3 | 85 |
| 2021 | 2 | 206 |
| 2022 | 1 | 30 |
| 2023 | 2 | 86 |
| 2024 | 4 | 126 |
| 2025 | 1 | 29 |
| 2026 | 1 | 267 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name InMode , Ltd. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent InMode , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251254 | Ignite RF System | GEI | 2026-01-15 | 267 |
| K251632 | Optimas MAX System | GEX | 2025-06-26 | 29 |
| K242598 | DEFINE System (AG612444A) | PBX | 2024-11-14 | 76 |
| K240780 | InMode RF System | GEI | 2024-07-24 | 125 |
| K240017 | InMode System with the Morpheus8 90 Applicator | GEI | 2024-06-13 | 163 |
| K233642 | InMode RF System | GEI | 2024-03-20 | 128 |
| K231495 | The Evolve System with the Transform Applicator | GEI | 2023-10-13 | 143 |
| K231790 | The InMode System with the Morpheus8 Applicators | GEI | 2023-07-20 | 30 |
| K221571 | InMode Multi-system | GEX | 2022-06-30 | 30 |
| K210877 | Evolve System with the T3 Applicator | PBX | 2021-07-19 | 117 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named InMode , 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.
SEC filings
InMode Ltd. (INMD): EDGAR filings, CIK 1742692. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under InMode , Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
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 MD , Ltd. (21 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under InMode , Ltd.?
FDA lists 15 510(k) clearances under the applicant name “InMode , Ltd.” (first 2019, latest 2026), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by InMode , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name InMode , Ltd. is 117 days. Since 2017: 117 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under InMode , Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 8); GEX (Powered Laser Surgical Instrument, 2); IPF (Stimulator, Muscle, Powered, 2).
Next steps
- See all 15 InMode , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, InMode , 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.