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DEKA LUXEA

Model M117B1 · EL.EN. SPA · DI 08057017760429

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

ONF — Powered Light Based Non-Laser Surgical Instrument With Thermal Effect · Class II · 21 CFR 878.4810

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 6.58/device2019-02: 0 reports for this device; peer average 7.06/device2019-03: 0 reports for this device; peer average 7.9/device2019-04: 0 reports for this device; peer average 5.74/device2019-05: 0 reports for this device; peer average 5.7/device2019-06: 0 reports for this device; peer average 7.96/device2019-07: 0 reports for this device; peer average 5.59/device2019-08: 0 reports for this device; peer average 7.27/device2019-09: 0 reports for this device; peer average 6.86/device2019-10: 0 reports for this device; peer average 8.39/device2019-11: 0 reports for this device; peer average 6.84/device2019-12: 0 reports for this device; peer average 7.11/device2020-01: 0 reports for this device; peer average 6.49/device2020-02: 0 reports for this device; peer average 7/device2020-03: 0 reports for this device; peer average 9.83/device2020-04: 0 reports for this device; peer average 5.89/device2020-05: 0 reports for this device; peer average 6.07/device2020-06: 0 reports for this device; peer average 5.56/device2020-07: 0 reports for this device; peer average 6.66/device2020-08: 0 reports for this device; peer average 5.26/device2020-09: 0 reports for this device; peer average 5.57/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 7.3/device2021-01: 0 reports for this device; peer average 7.81/device2021-02: 0 reports for this device; peer average 9.12/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 8.07/device2021-08: 0 reports for this device; peer average 7.37/device2021-09: 0 reports for this device; peer average 6.03/device2021-10: 0 reports for this device; peer average 6.91/device2021-11: 0 reports for this device; peer average 7.26/device2021-12: 0 reports for this device; peer average 5.1/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 5.41/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 4.41/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 5.97/device2023-04: 0 reports for this device; peer average 4.66/device2023-05: 0 reports for this device; peer average 5.49/device2023-06: 0 reports for this device; peer average 4.33/device2023-07: 0 reports for this device; peer average 4.87/device2023-08: 0 reports for this device; peer average 4.69/device2023-09: 0 reports for this device; peer average 3.61/device2023-10: 0 reports for this device; peer average 4.7/device2023-11: 0 reports for this device; peer average 4.2/device2023-12: 0 reports for this device; peer average 3.75/device2024-01: 0 reports for this device; peer average 3.45/device2024-02: 0 reports for this device; peer average 4.34/device2024-03: 0 reports for this device; peer average 4.74/device2024-04: 0 reports for this device; peer average 3.97/device2024-05: 0 reports for this device; peer average 4.68/device2024-06: 0 reports for this device; peer average 4.39/device2024-07: 0 reports for this device; peer average 4.03/device2024-08: 0 reports for this device; peer average 5.4/device2024-09: 0 reports for this device; peer average 4.29/device2024-10: 0 reports for this device; peer average 4.81/device2024-11: 0 reports for this device; peer average 4.65/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 4.78/device2025-03: 0 reports for this device; peer average 6.2/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 5.5/device2025-07: 0 reports for this device; peer average 5.66/device2025-08: 0 reports for this device; peer average 6.29/device2025-09: 0 reports for this device; peer average 5.13/device2025-10: 0 reports for this device; peer average 5.4/device2025-11: 0 reports for this device; peer average 4.89/device2025-12: 0 reports for this device; peer average 5.38/device2026-01: 0 reports for this device; peer average 5.92/device2026-02: 0 reports for this device; peer average 5.86/device2026-03: 0 reports for this device; peer average 5.43/device2026-04: 0 reports for this device; peer average 5.4/device2026-05: 0 reports for this device; peer average 5.64/device2026-06: 0 reports for this device; peer average 6.54/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.58
2019-0207.06
2019-0307.9
2019-0405.74
2019-0505.7
2019-0607.96
2019-0705.59
2019-0807.27
2019-0906.86
2019-1008.39
2019-1106.84
2019-1207.11
2020-0106.49
2020-0207
2020-0309.83
2020-0405.89
2020-0506.07
2020-0605.56
2020-0706.66
2020-0805.26
2020-0905.57
2020-1005.04
2020-1104.8
2020-1207.3
2021-0107.81
2021-0209.12
2021-0307.87
2021-0405.99
2021-0508.19
2021-0607.39
2021-0708.07
2021-0807.37
2021-0906.03
2021-1006.91
2021-1107.26
2021-1205.1
2022-0104.13
2022-0205.61
2022-0304.39
2022-0406.62
2022-0504.93
2022-0604.79
2022-0704.76
2022-0805.41
2022-0904.09
2022-1006.06
2022-1104.41
2022-1205.1
2023-0105.09
2023-0206.14
2023-0305.97
2023-0404.66
2023-0505.49
2023-0604.33
2023-0704.87
2023-0804.69
2023-0903.61
2023-1004.7
2023-1104.2
2023-1203.75
2024-0103.45
2024-0204.34
2024-0304.74
2024-0403.97
2024-0504.68
2024-0604.39
2024-0704.03
2024-0805.4
2024-0904.29
2024-1004.81
2024-1104.65
2024-1204.78
2025-0104.69
2025-0204.78
2025-0306.2
2025-0405.74
2025-0504.77
2025-0605.5
2025-0705.66
2025-0806.29
2025-0905.13
2025-1005.4
2025-1104.89
2025-1205.38
2026-0105.92
2026-0205.86
2026-0305.43
2026-0405.4
2026-0505.64
2026-0606.54
This device (reports/month)Average device in GEX, ONF (reports/device/month)

Regulatory clearances

  • K192539 SESE 2019-12-16 (k number procode)

Predicate lineage

K192539 — cites (transitively): K020941 (d1), K072564 (d1), K103288 (d1), K142860 (d1), K150516 (d1), K152714 (d1), K082039 (d2), K082040 (d2), K040081 (d2), K043173 (d2), K060448 (d2), K063074 (d2), K083733 (d2), K130028 (d2), K131095 (d2), K111303 (d2), K143519 (d2), K050047 (d3), K060069 (d3), K082876 (d3), K091420 (d3), K110907 (d3), K111851 (d3), K140009 (d3), K033549 (d4), K041086 (d4), K070298 (d4), K101506 (d4), K050900 (d4), K053628 (d4), K033768 (d4), K042165 (d4), K050370 (d4), K080318 (d4), K083207 (d4), K083848 (d4), K090571 (d4), K101916 (d4), K102716 (d4), K112031 (d4), K060301 (d5), K063571 (d5), K071152 (d5), K071768 (d5), K073583 (d5), K080244 (d5), K083900 (d5), K090195 (d5), K091446 (d5), K100270 (d5), K023881 (d5), K042630 (d5), K050382 (d5), K060033 (d5), K070284 (d5), K070388 (d5), K072868 (d5), K081324 (d5), K081352 (d5), K082225 (d5), K082230 (d5), K083613 (d5), K083899 (d5), K052874 (d5), K024088 (d6), K032863 (d6), K050824 (d6), K071295 (d6), K072682 (d6), K073063 (d6), K080121 (d6), K083682 (d6), K090164 (d6), K902871 (d6), K923599 (d6), K944474 (d6), K944704 (d6), K944965 (d6), K951760 (d6), K992866 (d6) — cited as predicate by K200616, K202258, K211821, K212790, K220794, K234057

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

Manufacturer compliance record — EL.EN. SPA

Nothing in the loaded window.