Contoura - InMode RF™
Model InMode RF™ - Black-Blue · INMODE M.D LTD · DI 07290016633344
GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400
PBX — Massager, Vacuum, Radio Frequency Induced Heat · Class II · 21 CFR 878.4400
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.78 |
| 2019-02 | 0 | 4.35 |
| 2019-03 | 0 | 4.42 |
| 2019-04 | 0 | 6.06 |
| 2019-05 | 0 | 4.8 |
| 2019-06 | 0 | 5.04 |
| 2019-07 | 0 | 5.86 |
| 2019-08 | 0 | 6.1 |
| 2019-09 | 0 | 4.99 |
| 2019-10 | 0 | 5.83 |
| 2019-11 | 0 | 5.62 |
| 2019-12 | 0 | 5.41 |
| 2020-01 | 0 | 4.81 |
| 2020-02 | 0 | 5.57 |
| 2020-03 | 0 | 5.68 |
| 2020-04 | 0 | 3.57 |
| 2020-05 | 0 | 3.76 |
| 2020-06 | 0 | 5.14 |
| 2020-07 | 0 | 6.56 |
| 2020-08 | 0 | 4.64 |
| 2020-09 | 0 | 5.86 |
| 2020-10 | 0 | 5.52 |
| 2020-11 | 0 | 5.14 |
| 2020-12 | 0 | 5.31 |
| 2021-01 | 0 | 5.17 |
| 2021-02 | 0 | 4.89 |
| 2021-03 | 0 | 5.7 |
| 2021-04 | 0 | 5.26 |
| 2021-05 | 0 | 5.12 |
| 2021-06 | 0 | 5.77 |
| 2021-07 | 0 | 4.86 |
| 2021-08 | 0 | 4.3 |
| 2021-09 | 0 | 4.77 |
| 2021-10 | 0 | 6.17 |
| 2021-11 | 0 | 5.57 |
| 2021-12 | 0 | 5.56 |
| 2022-01 | 0 | 5.04 |
| 2022-02 | 0 | 5.15 |
| 2022-03 | 0 | 5.75 |
| 2022-04 | 0 | 4.98 |
| 2022-05 | 0 | 5.75 |
| 2022-06 | 0 | 6.3 |
| 2022-07 | 0 | 4.36 |
| 2022-08 | 0 | 4.59 |
| 2022-09 | 0 | 5 |
| 2022-10 | 0 | 4.76 |
| 2022-11 | 0 | 4.61 |
| 2022-12 | 0 | 4.02 |
| 2023-01 | 0 | 5.52 |
| 2023-02 | 0 | 4.57 |
| 2023-03 | 0 | 4.85 |
| 2023-04 | 0 | 4.78 |
| 2023-05 | 0 | 5.11 |
| 2023-06 | 0 | 4.78 |
| 2023-07 | 0 | 4.82 |
| 2023-08 | 0 | 4.44 |
| 2023-09 | 0 | 5.23 |
| 2023-10 | 0 | 5.1 |
| 2023-11 | 0 | 4.36 |
| 2023-12 | 0 | 4.77 |
| 2024-01 | 0 | 5.52 |
| 2024-02 | 0 | 5.44 |
| 2024-03 | 0 | 6.13 |
| 2024-04 | 0 | 6.04 |
| 2024-05 | 0 | 6.25 |
| 2024-06 | 0 | 5.36 |
| 2024-07 | 0 | 5.05 |
| 2024-08 | 0 | 5.01 |
| 2024-09 | 0 | 5.18 |
| 2024-10 | 0 | 5.69 |
| 2024-11 | 0 | 5.27 |
| 2024-12 | 0 | 4.04 |
| 2025-01 | 0 | 5.17 |
| 2025-02 | 0 | 4.46 |
| 2025-03 | 0 | 6.26 |
| 2025-04 | 0 | 4.39 |
| 2025-05 | 0 | 5.12 |
| 2025-06 | 0 | 5.05 |
| 2025-07 | 0 | 5.18 |
| 2025-08 | 0 | 5.41 |
| 2025-09 | 0 | 4.81 |
| 2025-10 | 0 | 5.12 |
| 2025-11 | 0 | 5.49 |
| 2025-12 | 0 | 5.79 |
| 2026-01 | 0 | 5.6 |
| 2026-02 | 0 | 5.98 |
| 2026-03 | 0 | 6.18 |
| 2026-04 | 0 | 5.36 |
| 2026-05 | 0 | 6.17 |
| 2026-06 | 0 | 5.56 |
Regulatory clearances
- K180189 SESE 2018-06-01 (k number procode)
- K172302 SESE 2017-12-08 (k number procode)
- K160329 SESE 2016-08-19 (k number procode)
- K151793 SESE 2016-02-19 (k number procode)
- K151273 SESE 2016-01-04 (k number procode)
- K140926 SESE 2014-12-03 (k number procode)
Predicate lineage
K131362 — cites (transitively): K090221 (d1) — cited as predicate by K160329, K183450, K201150, K221571
K140926 — cites (transitively): K083461 (d1) — cited as predicate by K151273, K201150, K221571
K151273 — cites (transitively): K130501 (d1), K140926 (d1), K083461 (d2), K101510 (d2) — cited as predicate by K180189, K201150, K221571
K151793 — cites (transitively): K130689 (d1), K000944 (d2), K082834 (d2) — cited as predicate by K163190
K160329 — cites (transitively): K131362 (d1), K090221 (d2) — cited as predicate by K170637, K181095, K201150, K221571
K172302 — cites (transitively): K153568 (d1), K150035 (d2), K090221 (d3), K142093 (d3), K133837 (d4), K113810 (d5) — cited as predicate by K183450, K201150, K221571, K243139
K180189 — cites (transitively): K081365 (d1), K082451 (d1), K102461 (d1), K130501 (d1), K142438 (d1), K151019 (d1), K151273 (d1), K073572 (d2), K083461 (d2), K101510 (d2), K073227 (d2), K073229 (d2), K132373 (d2), K140400 (d2), K121302 (d2), K140926 (d2), K103128 (d3), K123589 (d3), K122845 (d3), K123307 (d3), K014165 (d4), K031003 (d4), K050325 (d4), K062549 (d4), K062996 (d4), K063729 (d4), K992869 (d4), K102235 (d4), K050438 (d4), K122742 (d4), K061113 (d4), K971214 (d4), K002858 (d5), K013823 (d5), K043473 (d5), K063428 (d5), K951725 (d5), K033621 (d5) — cited as predicate by K192545, K192695, K201150, K221571
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — INMODE M.D LTD
Nothing in the loaded window.