Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inmode MD , Ltd. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
233 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210492 | InMode RF Pro System | Inmode MD , Ltd. | 2021-07-12 | 143 | 0 |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD , Ltd. | 2019-12-27 | 92 | 0 |
| K191855 | EmFace Device | Inmode MD , Ltd. | 2019-10-29 | 111 | 0 |
| K183450 | EmBody System | Inmode MD , Ltd. | 2019-06-20 | 190 | 0 |
| K182325 | InMode RF System | Inmode MD , Ltd. | 2018-09-26 | 30 | 0 |
| K180719 | InMode Diolaze System | Inmode MD , Ltd. | 2018-06-14 | 87 | 0 |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD , Ltd. | 2018-06-01 | 129 | 0 |
| K173677 | InMode VLaze | Inmode MD , Ltd. | 2018-02-23 | 85 | 0 |
| K172302 | InMode PLUS System | Inmode MD , Ltd. | 2017-12-08 | 130 | 0 |
| K171593 | InMode RF System | Inmode MD , Ltd. | 2017-10-10 | 132 | 0 |
| K170738 | InMode Diolaze XL | Inmode MD , Ltd. | 2017-08-07 | 150 | 0 |
| K163190 | InMode RF System | Inmode MD , Ltd. | 2016-12-12 | 28 | 0 |
| K160329 | InMode System MiniFX Handpiece | Inmode MD , Ltd. | 2016-08-19 | 196 | 0 |
| K153568 | InMode Plus System | Inmode MD , Ltd. | 2016-07-12 | 211 | 0 |
| K151793 | InMode RF System | Inmode MD , Ltd. | 2016-02-19 | 233 | 0 |
| K151273 | InMode FRF Applicator | Inmode MD , Ltd. | 2016-01-04 | 236 | 0 |
| K142952 | InMode Diolaze Device | Inmode MD , Ltd. | 2015-01-13 | 95 | 0 |
| K140926 | INMODE WMFACE DEVICE | Inmode MD , Ltd. | 2014-12-03 | 236 | 0 |
| K131362 | INMODE WMBODY DEVICE | Inmode MD , Ltd. | 2013-10-08 | 148 | 0 |
| K123860 | INMODE SR IPL DEVICE | Inmode MD , Ltd. | 2013-04-02 | 109 | 0 |
| K123682 | INMODE HAIR REMOVAL (HR) DEVICE | Inmode MD , Ltd. | 2013-02-27 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda