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VIVACE ULTRA

Model VERSION 1.0 · Aesthetics Biomedical, Inc. · DI G055ABMVIVM020

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

IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560

OUH — Skin Resurfacing Rf Applicator · Class II · 21 CFR 878.4400

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 (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.

24692019-01: 0 reports for this device; peer average 6.74/device2019-02: 0 reports for this device; peer average 4.62/device2019-03: 0 reports for this device; peer average 4.67/device2019-04: 0 reports for this device; peer average 6.09/device2019-05: 0 reports for this device; peer average 5.14/device2019-06: 0 reports for this device; peer average 5.38/device2019-07: 0 reports for this device; peer average 5.99/device2019-08: 0 reports for this device; peer average 6.7/device2019-09: 0 reports for this device; peer average 5.17/device2019-10: 0 reports for this device; peer average 5.8/device2019-11: 0 reports for this device; peer average 5.56/device2019-12: 0 reports for this device; peer average 5.52/device2020-01: 0 reports for this device; peer average 4.67/device2020-02: 0 reports for this device; peer average 5.7/device2020-03: 0 reports for this device; peer average 5.96/device2020-04: 0 reports for this device; peer average 4.16/device2020-05: 0 reports for this device; peer average 3.8/device2020-06: 0 reports for this device; peer average 4.98/device2020-07: 0 reports for this device; peer average 6.35/device2020-08: 0 reports for this device; peer average 4.51/device2020-09: 0 reports for this device; peer average 5.67/device2020-10: 0 reports for this device; peer average 5.37/device2020-11: 0 reports for this device; peer average 5.12/device2020-12: 0 reports for this device; peer average 5.56/device2021-01: 0 reports for this device; peer average 5.57/device2021-02: 0 reports for this device; peer average 4.9/device2021-03: 0 reports for this device; peer average 6.02/device2021-04: 0 reports for this device; peer average 5.29/device2021-05: 0 reports for this device; peer average 5.33/device2021-06: 0 reports for this device; peer average 6.15/device2021-07: 0 reports for this device; peer average 5.53/device2021-08: 0 reports for this device; peer average 4.88/device2021-09: 0 reports for this device; peer average 5.31/device2021-10: 0 reports for this device; peer average 6.14/device2021-11: 0 reports for this device; peer average 5.89/device2021-12: 0 reports for this device; peer average 6.24/device2022-01: 0 reports for this device; peer average 5.35/device2022-02: 0 reports for this device; peer average 5.43/device2022-03: 0 reports for this device; peer average 6.03/device2022-04: 0 reports for this device; peer average 5.54/device2022-05: 0 reports for this device; peer average 6.37/device2022-06: 0 reports for this device; peer average 6.49/device2022-07: 0 reports for this device; peer average 4.77/device2022-08: 0 reports for this device; peer average 4.7/device2022-09: 0 reports for this device; peer average 4.91/device2022-10: 0 reports for this device; peer average 4.7/device2022-11: 0 reports for this device; peer average 4.52/device2022-12: 0 reports for this device; peer average 4.16/device2023-01: 0 reports for this device; peer average 5.44/device2023-02: 0 reports for this device; peer average 4.53/device2023-03: 0 reports for this device; peer average 4.98/device2023-04: 0 reports for this device; peer average 4.56/device2023-05: 0 reports for this device; peer average 5.08/device2023-06: 0 reports for this device; peer average 4.65/device2023-07: 0 reports for this device; peer average 4.72/device2023-08: 0 reports for this device; peer average 4.54/device2023-09: 0 reports for this device; peer average 5.23/device2023-10: 0 reports for this device; peer average 5.29/device2023-11: 0 reports for this device; peer average 4.54/device2023-12: 0 reports for this device; peer average 4.86/device2024-01: 0 reports for this device; peer average 5.68/device2024-02: 0 reports for this device; peer average 5.32/device2024-03: 0 reports for this device; peer average 6.14/device2024-04: 0 reports for this device; peer average 6/device2024-05: 0 reports for this device; peer average 5.99/device2024-06: 0 reports for this device; peer average 5.42/device2024-07: 0 reports for this device; peer average 5.04/device2024-08: 0 reports for this device; peer average 5.08/device2024-09: 0 reports for this device; peer average 5.26/device2024-10: 0 reports for this device; peer average 5.84/device2024-11: 0 reports for this device; peer average 5.01/device2024-12: 0 reports for this device; peer average 5.06/device2025-01: 0 reports for this device; peer average 5.09/device2025-02: 0 reports for this device; peer average 4.39/device2025-03: 0 reports for this device; peer average 6.01/device2025-04: 0 reports for this device; peer average 4.23/device2025-05: 0 reports for this device; peer average 4.88/device2025-06: 0 reports for this device; peer average 4.91/device2025-07: 0 reports for this device; peer average 4.92/device2025-08: 0 reports for this device; peer average 5.49/device2025-09: 0 reports for this device; peer average 5.27/device2025-10: 0 reports for this device; peer average 5.86/device2025-11: 0 reports for this device; peer average 7.1/device2025-12: 0 reports for this device; peer average 8.5/device2026-01: 0 reports for this device; peer average 7.37/device2026-02: 0 reports for this device; peer average 6.08/device2026-03: 0 reports for this device; peer average 6.57/device2026-04: 0 reports for this device; peer average 6.84/device2026-05: 0 reports for this device; peer average 8.06/device2026-06: 0 reports for this device; peer average 6.93/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.74
2019-0204.62
2019-0304.67
2019-0406.09
2019-0505.14
2019-0605.38
2019-0705.99
2019-0806.7
2019-0905.17
2019-1005.8
2019-1105.56
2019-1205.52
2020-0104.67
2020-0205.7
2020-0305.96
2020-0404.16
2020-0503.8
2020-0604.98
2020-0706.35
2020-0804.51
2020-0905.67
2020-1005.37
2020-1105.12
2020-1205.56
2021-0105.57
2021-0204.9
2021-0306.02
2021-0405.29
2021-0505.33
2021-0606.15
2021-0705.53
2021-0804.88
2021-0905.31
2021-1006.14
2021-1105.89
2021-1206.24
2022-0105.35
2022-0205.43
2022-0306.03
2022-0405.54
2022-0506.37
2022-0606.49
2022-0704.77
2022-0804.7
2022-0904.91
2022-1004.7
2022-1104.52
2022-1204.16
2023-0105.44
2023-0204.53
2023-0304.98
2023-0404.56
2023-0505.08
2023-0604.65
2023-0704.72
2023-0804.54
2023-0905.23
2023-1005.29
2023-1104.54
2023-1204.86
2024-0105.68
2024-0205.32
2024-0306.14
2024-0406
2024-0505.99
2024-0605.42
2024-0705.04
2024-0805.08
2024-0905.26
2024-1005.84
2024-1105.01
2024-1205.06
2025-0105.09
2025-0204.39
2025-0306.01
2025-0404.23
2025-0504.88
2025-0604.91
2025-0704.92
2025-0805.49
2025-0905.27
2025-1005.86
2025-1107.1
2025-1208.5
2026-0107.37
2026-0206.08
2026-0306.57
2026-0406.84
2026-0508.06
2026-0606.93
This device (reports/month)Average device in GEI, IYO, OUH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K221574 — cites (transitively): K180945 (d1), K192545 (d1), K121481 (d2), K092761 (d2), K153727 (d2), K160469 (d2), K170325 (d2), K180189 (d2), K102372 (d3), K881276 (d3), K160312 (d3), K081365 (d3), K082451 (d3), K102461 (d3), K130501 (d3), K142438 (d3), K151019 (d3), K151273 (d3), K002002 (d4), K030362 (d4), K861036 (d4), K073572 (d4), K083461 (d4), K101510 (d4), K073227 (d4), K073229 (d4), K132373 (d4), K140400 (d4), K121302 (d4), K140926 (d4), K123573 (d4), K063001 (d5), K072159 (d5), K080496 (d5), K091115 (d5), 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)

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

Manufacturer compliance record — Aesthetics Biomedical, Inc.

  • VAI 2020-01-21 Aesthetics Biomedical, Inc. · 4 citations
  • VAI 2020-01-21 Aesthetics Biomedical, Inc. · 4 citations
  • NAI 2018-03-15 Aesthetics Biomedical, Inc. · 0 citations
  • NAI 2018-03-15 Aesthetics Biomedical, Inc. · 0 citations