Morpheus8V Applicator
Model AG609931A · INMODE M.D LTD · DI 07290016633696
GEI — Electrosurgical, Cutting & Coagulation & Accessories · 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 | 6.86 |
| 2019-02 | 0 | 4.35 |
| 2019-03 | 0 | 4.42 |
| 2019-04 | 0 | 6.12 |
| 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 | 5.85 |
| 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 | 5.55 |
| 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 | 5.14 |
| 2021-06 | 0 | 5.83 |
| 2021-07 | 0 | 4.89 |
| 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 | 5.78 |
| 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 | 4.04 |
| 2023-01 | 0 | 5.52 |
| 2023-02 | 0 | 4.59 |
| 2023-03 | 0 | 4.87 |
| 2023-04 | 0 | 4.78 |
| 2023-05 | 0 | 5.14 |
| 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 | 4.38 |
| 2023-12 | 0 | 4.79 |
| 2024-01 | 0 | 5.54 |
| 2024-02 | 0 | 5.46 |
| 2024-03 | 0 | 6.16 |
| 2024-04 | 0 | 6.04 |
| 2024-05 | 0 | 6.28 |
| 2024-06 | 0 | 5.39 |
| 2024-07 | 0 | 5.05 |
| 2024-08 | 0 | 5.01 |
| 2024-09 | 0 | 5.19 |
| 2024-10 | 0 | 5.7 |
| 2024-11 | 0 | 5.29 |
| 2024-12 | 0 | 4.06 |
| 2025-01 | 0 | 5.17 |
| 2025-02 | 0 | 4.46 |
| 2025-03 | 0 | 6.28 |
| 2025-04 | 0 | 4.39 |
| 2025-05 | 0 | 5.16 |
| 2025-06 | 0 | 5.08 |
| 2025-07 | 0 | 5.2 |
| 2025-08 | 0 | 5.45 |
| 2025-09 | 0 | 4.85 |
| 2025-10 | 0 | 5.14 |
| 2025-11 | 0 | 5.55 |
| 2025-12 | 0 | 5.81 |
| 2026-01 | 0 | 5.63 |
| 2026-02 | 0 | 5.98 |
| 2026-03 | 0 | 6.2 |
| 2026-04 | 0 | 5.43 |
| 2026-05 | 0 | 6.19 |
| 2026-06 | 0 | 5.56 |
Regulatory clearances
- K180189 SESE 2018-06-01 (k number procode)
Predicate lineage
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.