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Diode 3D Trio 4cm HP for Soprano Titanium

Model 1 · ALMA LASERS LTD. · DI 17290110121812

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

ILY — Lamp, Infrared, Therapeutic Heating · Class II · 21 CFR 890.5500

UDILibrary device dossier · generated 2026-09-14 · 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.

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 7.66/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 5.54/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 8.29/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 6.97/device2020-03: 0 reports for this device; peer average 9.72/device2020-04: 0 reports for this device; peer average 5.86/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 8.19/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: 0 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/device2023-02: 0 reports for this device; peer average 6.14/device2023-03: 0 reports for this device; peer average 5.97/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 3.75/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 4.71/device2024-04: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 4.66/device2024-06: 0 reports for this device; peer average 4.41/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 4.61/device2024-12: 0 reports for this device; peer average 4.58/device2025-01: 0 reports for this device; peer average 4.69/device2025-02: 0 reports for this device; peer average 4.78/device2025-03: 0 reports for this device; peer average 6.04/device2025-04: 0 reports for this device; peer average 5.74/device2025-05: 0 reports for this device; peer average 4.77/device2025-06: 0 reports for this device; peer average 5.61/device2025-07: 0 reports for this device; peer average 5.59/device2025-08: 0 reports for this device; peer average 6.41/device2025-09: 0 reports for this device; peer average 5.06/device2025-10: 0 reports for this device; peer average 5.34/device2025-11: 0 reports for this device; peer average 4.98/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 5.93/device2026-03: 0 reports for this device; peer average 5.47/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 6.55/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
2019-0307.66
2019-0405.74
2019-0505.67
2019-0608.04
2019-0705.54
2019-0807.54
2019-0906.99
2019-1008.29
2019-1106.91
2019-1207.31
2020-0106.52
2020-0206.97
2020-0309.72
2020-0405.86
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
2021-0708.19
2021-0807.46
2021-0906.11
2021-1006.91
2021-1107.38
2021-1205.17
2022-0104.13
2022-0205.61
2022-0304.39
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
2023-0206.14
2023-0305.97
2023-0404.95
2023-0505.49
2023-0604.37
2023-0704.92
2023-0804.69
2023-0903.65
2023-1004.81
2023-1104.25
2023-1203.75
2024-0103.49
2024-0204.41
2024-0304.71
2024-0404
2024-0504.66
2024-0604.41
2024-0704.09
2024-0805.4
2024-0904.33
2024-1004.81
2024-1104.61
2024-1204.58
2025-0104.69
2025-0204.78
2025-0306.04
2025-0405.74
2025-0504.77
2025-0605.61
2025-0705.59
2025-0806.41
2025-0905.06
2025-1005.34
2025-1104.98
2025-1205.44
2026-0105.92
2026-0205.93
2026-0305.47
2026-0405.51
2026-0505.78
2026-0606.55
This device (reports/month)Average device in GEX, ILY (reports/device/month)

Regulatory clearances

  • K222064 SESE 2022-10-12 (k number procode)

Predicate lineage

K222064 — cites (transitively): K172193 (d1), K050779 (d2), K140009 (d2), K170626 (d2), K033768 (d3), K042165 (d3), K050370 (d3), K080318 (d3), K083207 (d3), K083848 (d3), K090571 (d3), K101916 (d3), K102716 (d3), K112031 (d3), K132185 (d3), K153671 (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), K023954 (d4), K112715 (d4), K120235 (d4), K143723 (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), K033251 (d5), K090126 (d5), K093545 (d5), K093547 (d5), K101306 (d5), K103626 (d5), K050293 (d5), K083889 (d5), K093162 (d5), K113702 (d5), K132806 (d5), K990243 (d5), K083616 (d6), K021548 (d6) — cited as predicate by K222862, K230308, K230371, K230580, K242859, K250206, K252599

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

Manufacturer compliance record — ALMA LASERS LTD.

  • Warning Letter 2013-06-07 Alma Lasers, Inc.
  • Warning Letter 2013-06-07 Alma Lasers, Inc.
  • NAI 2013-12-11 Alma Lasers, Inc. · 0 citations
  • NAI 2013-12-11 Alma Lasers, Inc. · 0 citations
  • OAI 2013-01-29 Alma Lasers, Inc. · 0 citations
  • OAI 2013-01-29 Alma Lasers, Inc. · 0 citations