Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Morpheus8 Body (Blue)

Model AG609126A · INMODE M.D LTD · DI 07290016633672

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

UDILibrary device dossier · generated 2026-09-13 · 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 (15)

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.

Injury: 15

23572019-01: 0 reports for this device; peer average 6.86/device2019-02: 0 reports for this device; peer average 4.35/device2019-03: 0 reports for this device; peer average 4.42/device2019-04: 0 reports for this device; peer average 6.12/device2019-05: 0 reports for this device; peer average 4.8/device2019-06: 0 reports for this device; peer average 5.04/device2019-07: 0 reports for this device; peer average 5.86/device2019-08: 0 reports for this device; peer average 6.1/device2019-09: 0 reports for this device; peer average 4.99/device2019-10: 0 reports for this device; peer average 5.85/device2019-11: 0 reports for this device; peer average 5.62/device2019-12: 0 reports for this device; peer average 5.41/device2020-01: 0 reports for this device; peer average 4.81/device2020-02: 0 reports for this device; peer average 5.57/device2020-03: 0 reports for this device; peer average 5.68/device2020-04: 0 reports for this device; peer average 3.57/device2020-05: 0 reports for this device; peer average 3.76/device2020-06: 0 reports for this device; peer average 5.14/device2020-07: 0 reports for this device; peer average 6.56/device2020-08: 0 reports for this device; peer average 4.64/device2020-09: 0 reports for this device; peer average 5.86/device2020-10: 0 reports for this device; peer average 5.55/device2020-11: 0 reports for this device; peer average 5.14/device2020-12: 0 reports for this device; peer average 5.31/device2021-01: 0 reports for this device; peer average 5.17/device2021-02: 0 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.7/device2021-04: 0 reports for this device; peer average 5.26/device2021-05: 0 reports for this device; peer average 5.14/device2021-06: 0 reports for this device; peer average 5.83/device2021-07: 0 reports for this device; peer average 4.89/device2021-08: 0 reports for this device; peer average 4.3/device2021-09: 0 reports for this device; peer average 4.77/device2021-10: 0 reports for this device; peer average 6.17/device2021-11: 0 reports for this device; peer average 5.57/device2021-12: 0 reports for this device; peer average 5.56/device2022-01: 0 reports for this device; peer average 5.04/device2022-02: 0 reports for this device; peer average 5.15/device2022-03: 0 reports for this device; peer average 5.75/device2022-04: 0 reports for this device; peer average 4.98/device2022-05: 0 reports for this device; peer average 5.78/device2022-06: 0 reports for this device; peer average 6.3/device2022-07: 0 reports for this device; peer average 4.36/device2022-08: 0 reports for this device; peer average 4.59/device2022-09: 0 reports for this device; peer average 5/device2022-10: 0 reports for this device; peer average 4.76/device2022-11: 0 reports for this device; peer average 4.61/device2022-12: 0 reports for this device; peer average 4.04/device2023-01: 0 reports for this device; peer average 5.52/device2023-02: 0 reports for this device; peer average 4.59/device2023-03: 0 reports for this device; peer average 4.87/device2023-04: 0 reports for this device; peer average 4.78/device2023-05: 0 reports for this device; peer average 5.14/device2023-06: 2 reports for this device; peer average 4.78/device2023-07: 2 reports for this device; peer average 4.82/device2023-08: 1 reports for this device; peer average 4.44/device2023-09: 0 reports for this device; peer average 5.23/device2023-10: 0 reports for this device; peer average 5.1/device2023-11: 2 reports for this device; peer average 4.38/device2023-12: 0 reports for this device; peer average 4.79/device2024-01: 0 reports for this device; peer average 5.54/device2024-02: 0 reports for this device; peer average 5.46/device2024-03: 0 reports for this device; peer average 6.16/device2024-04: 0 reports for this device; peer average 6.04/device2024-05: 0 reports for this device; peer average 6.28/device2024-06: 2 reports for this device; peer average 5.39/device2024-07: 0 reports for this device; peer average 5.05/device2024-08: 0 reports for this device; peer average 5.01/device2024-09: 3 reports for this device; peer average 5.19/device2024-10: 0 reports for this device; peer average 5.7/device2024-11: 0 reports for this device; peer average 5.29/device2024-12: 0 reports for this device; peer average 4.06/device2025-01: 0 reports for this device; peer average 5.17/device2025-02: 0 reports for this device; peer average 4.46/device2025-03: 2 reports for this device; peer average 6.28/device2025-04: 0 reports for this device; peer average 4.39/device2025-05: 0 reports for this device; peer average 5.16/device2025-06: 0 reports for this device; peer average 5.08/device2025-07: 0 reports for this device; peer average 5.2/device2025-08: 1 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 4.85/device2025-10: 0 reports for this device; peer average 5.14/device2025-11: 0 reports for this device; peer average 5.55/device2025-12: 0 reports for this device; peer average 5.81/device2026-01: 0 reports for this device; peer average 5.63/device2026-02: 0 reports for this device; peer average 5.98/device2026-03: 0 reports for this device; peer average 6.2/device2026-04: 0 reports for this device; peer average 5.43/device2026-05: 0 reports for this device; peer average 6.19/device2026-06: 0 reports for this device; peer average 5.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.86
2019-0204.35
2019-0304.42
2019-0406.12
2019-0504.8
2019-0605.04
2019-0705.86
2019-0806.1
2019-0904.99
2019-1005.85
2019-1105.62
2019-1205.41
2020-0104.81
2020-0205.57
2020-0305.68
2020-0403.57
2020-0503.76
2020-0605.14
2020-0706.56
2020-0804.64
2020-0905.86
2020-1005.55
2020-1105.14
2020-1205.31
2021-0105.17
2021-0204.89
2021-0305.7
2021-0405.26
2021-0505.14
2021-0605.83
2021-0704.89
2021-0804.3
2021-0904.77
2021-1006.17
2021-1105.57
2021-1205.56
2022-0105.04
2022-0205.15
2022-0305.75
2022-0404.98
2022-0505.78
2022-0606.3
2022-0704.36
2022-0804.59
2022-0905
2022-1004.76
2022-1104.61
2022-1204.04
2023-0105.52
2023-0204.59
2023-0304.87
2023-0404.78
2023-0505.14
2023-0624.78
2023-0724.82
2023-0814.44
2023-0905.23
2023-1005.1
2023-1124.38
2023-1204.79
2024-0105.54
2024-0205.46
2024-0306.16
2024-0406.04
2024-0506.28
2024-0625.39
2024-0705.05
2024-0805.01
2024-0935.19
2024-1005.7
2024-1105.29
2024-1204.06
2025-0105.17
2025-0204.46
2025-0326.28
2025-0404.39
2025-0505.16
2025-0605.08
2025-0705.2
2025-0815.45
2025-0904.85
2025-1005.14
2025-1105.55
2025-1205.81
2026-0105.63
2026-0205.98
2026-0306.2
2026-0405.43
2026-0506.19
2026-0605.56
This device (reports/month)Average device in GEI (reports/device/month)

Regulatory clearances

  • K200947 SESE 2020-07-02 (k number procode)
  • K192695 SESE 2019-12-27 (k number procode)

Predicate lineage

K192695 — cites (transitively): K180189 (d1), K081365 (d2), K082451 (d2), K102461 (d2), K130501 (d2), K142438 (d2), K151019 (d2), K151273 (d2), K073572 (d3), K083461 (d3), K101510 (d3), K073227 (d3), K073229 (d3), K132373 (d3), K140400 (d3), K121302 (d3), K140926 (d3), K103128 (d4), K123589 (d4), K122845 (d4), K123307 (d4), K014165 (d5), K031003 (d5), K050325 (d5), K062549 (d5), K062996 (d5), K063729 (d5), K992869 (d5), K102235 (d5), K050438 (d5), K122742 (d5), K061113 (d5), K971214 (d5), K002858 (d6), K013823 (d6), K043473 (d6), K063428 (d6), K951725 (d6), K033621 (d6) — cited as predicate by K200947, K201150

K200947 — cites (transitively): K192695 (d1), K180189 (d2), K081365 (d3), K082451 (d3), K102461 (d3), K130501 (d3), K142438 (d3), K151019 (d3), K151273 (d3), K073572 (d4), K083461 (d4), K101510 (d4), K073227 (d4), K073229 (d4), K132373 (d4), K140400 (d4), K121302 (d4), K140926 (d4), K103128 (d5), K123589 (d5), K122845 (d5), K123307 (d5), K014165 (d6), K031003 (d6), K050325 (d6), K062549 (d6), K062996 (d6), K063729 (d6), K992869 (d6), K102235 (d6), K050438 (d6), K122742 (d6), K061113 (d6), K971214 (d6), K002858 (d7), K013823 (d7), K043473 (d7), K063428 (d7), K951725 (d7), K033621 (d7) — cited as predicate by K201150, K221571, K231790, K240999

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — INMODE M.D LTD

Nothing in the loaded window.