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Accent Elite System 110V (Black)

Model 01 · ALMA LASERS LTD. · DI 17290110121768

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

IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat · Class II · 21 CFR 890.5300

ISA — Massager, Therapeutic, Electric · Class I · 21 CFR 890.5660

NUV — Massager, Vacuum, Light Induced Heating · Class II · 21 CFR 878.4810

UDILibrary device dossier · generated 2026-09-11 · 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.

23572019-01: 0 reports for this device; peer average 6.8/device2019-02: 0 reports for this device; peer average 4.3/device2019-03: 0 reports for this device; peer average 4.46/device2019-04: 0 reports for this device; peer average 6.04/device2019-05: 0 reports for this device; peer average 4.75/device2019-06: 0 reports for this device; peer average 4.92/device2019-07: 0 reports for this device; peer average 5.77/device2019-08: 0 reports for this device; peer average 6.06/device2019-09: 0 reports for this device; peer average 4.93/device2019-10: 0 reports for this device; peer average 5.76/device2019-11: 0 reports for this device; peer average 5.54/device2019-12: 0 reports for this device; peer average 5.38/device2020-01: 0 reports for this device; peer average 4.82/device2020-02: 0 reports for this device; peer average 5.54/device2020-03: 0 reports for this device; peer average 5.62/device2020-04: 0 reports for this device; peer average 3.54/device2020-05: 0 reports for this device; peer average 3.76/device2020-06: 0 reports for this device; peer average 5.1/device2020-07: 0 reports for this device; peer average 6.45/device2020-08: 0 reports for this device; peer average 4.58/device2020-09: 0 reports for this device; peer average 5.87/device2020-10: 0 reports for this device; peer average 5.58/device2020-11: 0 reports for this device; peer average 5.17/device2020-12: 0 reports for this device; peer average 5.26/device2021-01: 0 reports for this device; peer average 5.22/device2021-02: 0 reports for this device; peer average 4.85/device2021-03: 0 reports for this device; peer average 5.67/device2021-04: 0 reports for this device; peer average 5.19/device2021-05: 0 reports for this device; peer average 5.1/device2021-06: 0 reports for this device; peer average 5.72/device2021-07: 0 reports for this device; peer average 4.86/device2021-08: 0 reports for this device; peer average 4.32/device2021-09: 0 reports for this device; peer average 4.76/device2021-10: 0 reports for this device; peer average 6.16/device2021-11: 0 reports for this device; peer average 5.61/device2021-12: 0 reports for this device; peer average 5.57/device2022-01: 0 reports for this device; peer average 5.01/device2022-02: 0 reports for this device; peer average 5.06/device2022-03: 0 reports for this device; peer average 5.73/device2022-04: 0 reports for this device; peer average 5.05/device2022-05: 0 reports for this device; peer average 5.78/device2022-06: 0 reports for this device; peer average 6.24/device2022-07: 0 reports for this device; peer average 4.3/device2022-08: 0 reports for this device; peer average 4.58/device2022-09: 0 reports for this device; peer average 4.91/device2022-10: 0 reports for this device; peer average 4.73/device2022-11: 0 reports for this device; peer average 4.62/device2022-12: 0 reports for this device; peer average 4.01/device2023-01: 0 reports for this device; peer average 5.51/device2023-02: 0 reports for this device; peer average 4.55/device2023-03: 0 reports for this device; peer average 4.86/device2023-04: 0 reports for this device; peer average 4.74/device2023-05: 0 reports for this device; peer average 5.09/device2023-06: 0 reports for this device; peer average 4.79/device2023-07: 0 reports for this device; peer average 4.77/device2023-08: 0 reports for this device; peer average 4.35/device2023-09: 0 reports for this device; peer average 5.13/device2023-10: 0 reports for this device; peer average 5.08/device2023-11: 0 reports for this device; peer average 4.29/device2023-12: 0 reports for this device; peer average 4.74/device2024-01: 0 reports for this device; peer average 5.48/device2024-02: 0 reports for this device; peer average 5.39/device2024-03: 0 reports for this device; peer average 6.09/device2024-04: 0 reports for this device; peer average 5.99/device2024-05: 0 reports for this device; peer average 6.21/device2024-06: 0 reports for this device; peer average 5.28/device2024-07: 0 reports for this device; peer average 4.99/device2024-08: 0 reports for this device; peer average 4.97/device2024-09: 0 reports for this device; peer average 5.16/device2024-10: 0 reports for this device; peer average 5.63/device2024-11: 0 reports for this device; peer average 5.2/device2024-12: 0 reports for this device; peer average 4.06/device2025-01: 0 reports for this device; peer average 5.14/device2025-02: 0 reports for this device; peer average 4.47/device2025-03: 0 reports for this device; peer average 6.22/device2025-04: 0 reports for this device; peer average 4.36/device2025-05: 0 reports for this device; peer average 5.12/device2025-06: 0 reports for this device; peer average 5.04/device2025-07: 0 reports for this device; peer average 5.1/device2025-08: 0 reports for this device; peer average 5.31/device2025-09: 0 reports for this device; peer average 4.73/device2025-10: 0 reports for this device; peer average 5.03/device2025-11: 0 reports for this device; peer average 5.45/device2025-12: 0 reports for this device; peer average 5.77/device2026-01: 0 reports for this device; peer average 5.6/device2026-02: 0 reports for this device; peer average 5.96/device2026-03: 0 reports for this device; peer average 6.1/device2026-04: 0 reports for this device; peer average 5.38/device2026-05: 0 reports for this device; peer average 6.15/device2026-06: 0 reports for this device; peer average 5.52/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.8
2019-0204.3
2019-0304.46
2019-0406.04
2019-0504.75
2019-0604.92
2019-0705.77
2019-0806.06
2019-0904.93
2019-1005.76
2019-1105.54
2019-1205.38
2020-0104.82
2020-0205.54
2020-0305.62
2020-0403.54
2020-0503.76
2020-0605.1
2020-0706.45
2020-0804.58
2020-0905.87
2020-1005.58
2020-1105.17
2020-1205.26
2021-0105.22
2021-0204.85
2021-0305.67
2021-0405.19
2021-0505.1
2021-0605.72
2021-0704.86
2021-0804.32
2021-0904.76
2021-1006.16
2021-1105.61
2021-1205.57
2022-0105.01
2022-0205.06
2022-0305.73
2022-0405.05
2022-0505.78
2022-0606.24
2022-0704.3
2022-0804.58
2022-0904.91
2022-1004.73
2022-1104.62
2022-1204.01
2023-0105.51
2023-0204.55
2023-0304.86
2023-0404.74
2023-0505.09
2023-0604.79
2023-0704.77
2023-0804.35
2023-0905.13
2023-1005.08
2023-1104.29
2023-1204.74
2024-0105.48
2024-0205.39
2024-0306.09
2024-0405.99
2024-0506.21
2024-0605.28
2024-0704.99
2024-0804.97
2024-0905.16
2024-1005.63
2024-1105.2
2024-1204.06
2025-0105.14
2025-0204.47
2025-0306.22
2025-0404.36
2025-0505.12
2025-0605.04
2025-0705.1
2025-0805.31
2025-0904.73
2025-1005.03
2025-1105.45
2025-1205.77
2026-0105.6
2026-0205.96
2026-0306.1
2026-0405.38
2026-0506.15
2026-0605.52
This device (reports/month)Average device in GEI, IMI, ISA, NUV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K160075 — cites (transitively): K042000 (d1), K082622 (d1), K091615 (d1), K101147 (d1), K121150 (d1), K141237 (d1), K952536 (d1), K024307 (d2), K053041 (d2), K883893 (d2), K982830 (d2), K070004 (d2), K072699 (d2), K083461 (d2), K090025 (d2), K101510 (d2), K120513 (d2), K072564 (d2), K140009 (d2), K052936 (d3), K073572 (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), 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)

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