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InMode

Model AG606991A · INMODE M.D LTD · DI 07290016633375

GEX — Powered Laser Surgical Instrument · Class II · 21 CFR 878.4810

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 (1)

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: 1

257102019-01: 0 reports for this device; peer average 6.66/device2019-02: 0 reports for this device; peer average 7.13/device2019-03: 0 reports for this device; peer average 7.97/device2019-04: 0 reports for this device; peer average 5.74/device2019-05: 0 reports for this device; peer average 5.67/device2019-06: 0 reports for this device; peer average 8.04/device2019-07: 0 reports for this device; peer average 5.59/device2019-08: 0 reports for this device; peer average 7.54/device2019-09: 0 reports for this device; peer average 6.99/device2019-10: 0 reports for this device; peer average 8.39/device2019-11: 0 reports for this device; peer average 6.91/device2019-12: 0 reports for this device; peer average 7.31/device2020-01: 0 reports for this device; peer average 6.52/device2020-02: 0 reports for this device; peer average 7.04/device2020-03: 0 reports for this device; peer average 9.95/device2020-04: 0 reports for this device; peer average 5.93/device2020-05: 0 reports for this device; peer average 6.07/device2020-06: 0 reports for this device; peer average 5.62/device2020-07: 0 reports for this device; peer average 6.73/device2020-08: 0 reports for this device; peer average 5.26/device2020-09: 0 reports for this device; peer average 5.6/device2020-10: 0 reports for this device; peer average 5.04/device2020-11: 0 reports for this device; peer average 4.8/device2020-12: 0 reports for this device; peer average 7.4/device2021-01: 0 reports for this device; peer average 8.38/device2021-02: 0 reports for this device; peer average 9.28/device2021-03: 0 reports for this device; peer average 7.87/device2021-04: 0 reports for this device; peer average 5.99/device2021-05: 0 reports for this device; peer average 8.19/device2021-06: 0 reports for this device; peer average 7.39/device2021-07: 0 reports for this device; peer average 8.33/device2021-08: 0 reports for this device; peer average 7.46/device2021-09: 0 reports for this device; peer average 6.11/device2021-10: 0 reports for this device; peer average 6.91/device2021-11: 0 reports for this device; peer average 7.38/device2021-12: 0 reports for this device; peer average 5.17/device2022-01: 0 reports for this device; peer average 4.13/device2022-02: 0 reports for this device; peer average 5.61/device2022-03: 1 reports for this device; peer average 4.39/device2022-04: 0 reports for this device; peer average 6.62/device2022-05: 0 reports for this device; peer average 4.93/device2022-06: 0 reports for this device; peer average 4.79/device2022-07: 0 reports for this device; peer average 4.76/device2022-08: 0 reports for this device; peer average 5.5/device2022-09: 0 reports for this device; peer average 4.09/device2022-10: 0 reports for this device; peer average 6.06/device2022-11: 0 reports for this device; peer average 4.47/device2022-12: 0 reports for this device; peer average 5.1/device2023-01: 0 reports for this device; peer average 5.09/device2023-02: 0 reports for this device; peer average 6.14/device2023-03: 0 reports for this device; peer average 6.03/device2023-04: 0 reports for this device; peer average 4.95/device2023-05: 0 reports for this device; peer average 5.49/device2023-06: 0 reports for this device; peer average 4.37/device2023-07: 0 reports for this device; peer average 4.92/device2023-08: 0 reports for this device; peer average 4.69/device2023-09: 0 reports for this device; peer average 3.65/device2023-10: 0 reports for this device; peer average 4.81/device2023-11: 0 reports for this device; peer average 4.25/device2023-12: 0 reports for this device; peer average 3.8/device2024-01: 0 reports for this device; peer average 3.49/device2024-02: 0 reports for this device; peer average 4.41/device2024-03: 0 reports for this device; peer average 4.81/device2024-04: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 4.71/device2024-06: 0 reports for this device; peer average 4.45/device2024-07: 0 reports for this device; peer average 4.09/device2024-08: 0 reports for this device; peer average 5.4/device2024-09: 0 reports for this device; peer average 4.33/device2024-10: 0 reports for this device; peer average 4.81/device2024-11: 0 reports for this device; peer average 4.68/device2024-12: 0 reports for this device; peer average 4.78/device2025-01: 0 reports for this device; peer average 4.69/device2025-02: 0 reports for this device; peer average 4.79/device2025-03: 0 reports for this device; peer average 6.2/device2025-04: 0 reports for this device; peer average 5.89/device2025-05: 0 reports for this device; peer average 4.82/device2025-06: 0 reports for this device; peer average 5.66/device2025-07: 0 reports for this device; peer average 5.72/device2025-08: 0 reports for this device; peer average 6.41/device2025-09: 0 reports for this device; peer average 5.18/device2025-10: 0 reports for this device; peer average 5.43/device2025-11: 0 reports for this device; peer average 5/device2025-12: 0 reports for this device; peer average 5.44/device2026-01: 0 reports for this device; peer average 5.92/device2026-02: 0 reports for this device; peer average 5.83/device2026-03: 0 reports for this device; peer average 5.24/device2026-04: 0 reports for this device; peer average 5.51/device2026-05: 0 reports for this device; peer average 5.78/device2026-06: 0 reports for this device; peer average 6.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.66
2019-0207.13
2019-0307.97
2019-0405.74
2019-0505.67
2019-0608.04
2019-0705.59
2019-0807.54
2019-0906.99
2019-1008.39
2019-1106.91
2019-1207.31
2020-0106.52
2020-0207.04
2020-0309.95
2020-0405.93
2020-0506.07
2020-0605.62
2020-0706.73
2020-0805.26
2020-0905.6
2020-1005.04
2020-1104.8
2020-1207.4
2021-0108.38
2021-0209.28
2021-0307.87
2021-0405.99
2021-0508.19
2021-0607.39
2021-0708.33
2021-0807.46
2021-0906.11
2021-1006.91
2021-1107.38
2021-1205.17
2022-0104.13
2022-0205.61
2022-0314.39
2022-0406.62
2022-0504.93
2022-0604.79
2022-0704.76
2022-0805.5
2022-0904.09
2022-1006.06
2022-1104.47
2022-1205.1
2023-0105.09
2023-0206.14
2023-0306.03
2023-0404.95
2023-0505.49
2023-0604.37
2023-0704.92
2023-0804.69
2023-0903.65
2023-1004.81
2023-1104.25
2023-1203.8
2024-0103.49
2024-0204.41
2024-0304.81
2024-0404
2024-0504.71
2024-0604.45
2024-0704.09
2024-0805.4
2024-0904.33
2024-1004.81
2024-1104.68
2024-1204.78
2025-0104.69
2025-0204.79
2025-0306.2
2025-0405.89
2025-0504.82
2025-0605.66
2025-0705.72
2025-0806.41
2025-0905.18
2025-1005.43
2025-1105
2025-1205.44
2026-0105.92
2026-0205.83
2026-0305.24
2026-0405.51
2026-0505.78
2026-0606.56
This device (reports/month)Average device in GEX (reports/device/month)

Regulatory clearances

  • K180719 SESE 2018-06-14 (k number procode)
  • K173677 SESE 2018-02-23 (k number procode)
  • K170738 SESE 2017-08-07 (k number procode)
  • K123682 SESE 2013-02-27 (k number procode)

Predicate lineage

K123682 — cites (transitively): K001746 (d1), K090762 (d1) — cited as predicate by K142952

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

K160329 — cites (transitively): K131362 (d1), K090221 (d2) — cited as predicate by K170637, K181095, K201150, K221571

K170738 — cites (transitively): K151947 (d1), K053628 (d2) — cited as predicate by K173677, K180719

K172302 — cites (transitively): K153568 (d1), K150035 (d2), K090221 (d3), K142093 (d3), K133837 (d4), K113810 (d5) — cited as predicate by K183450, K201150, K221571, K243139

K173677 — cites (transitively): K133319 (d1), K160368 (d1), K170738 (d1), K022226 (d2), K053628 (d2), K151947 (d2) — cited as predicate by K221571

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

K180719 — cites (transitively): K141555 (d1), K143519 (d1), K170738 (d1), K113502 (d2), K133319 (d2), K111851 (d2), K140009 (d2), K151947 (d2), K050900 (d3), K053628 (d3), K022226 (d3), K033768 (d3), K042165 (d3), K050370 (d3), K080318 (d3), K083207 (d3), K083848 (d3), K090571 (d3), K101916 (d3), K102716 (d3), K112031 (d3), K023881 (d4), K042630 (d4), K050382 (d4), K060033 (d4), K070284 (d4), K070388 (d4), K072564 (d4), K072868 (d4), K081324 (d4), K081352 (d4), K082225 (d4), K082230 (d4), K083613 (d4), K083899 (d4), K090195 (d4), K100270 (d4), K101506 (d4), K052874 (d4), K024088 (d5), K032863 (d5), K050824 (d5), K071295 (d5), K072682 (d5), K073063 (d5), K080121 (d5), K083682 (d5), K090164 (d5), K902871 (d5), K923599 (d5), K944474 (d5), K944704 (d5), K944965 (d5), K951760 (d5), K992866 (d5), K033549 (d5), K071768 (d5), K073583 (d5), K083900 (d5), K091446 (d5), K060301 (d5), K063571 (d5), K071152 (d5), K080244 (d5) — cited as predicate by K191321, K221571

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

Manufacturer compliance record — INMODE M.D LTD

Nothing in the loaded window.