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Venus Legacy (120V)

Model LE120004 · Venus Concept Inc. · DI 00810060830833

PBX — Massager, Vacuum, Radio Frequency Induced Heat · 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.

23562019-01: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 6/device2022-07: 0 reports for this device; peer average 4/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 3.5/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 5/device2024-09: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 4/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.5/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 2/device010410100506070506071202030511120102030506070910111203050607080910111201030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0401.5
2019-1001
2020-1001
2021-0501
2021-0601
2021-0701
2022-0501
2022-0606
2022-0704
2022-1201
2023-0201
2023-0301
2023-0501
2023-1101
2023-1202
2024-0103
2024-0202
2024-0303.5
2024-0502
2024-0601
2024-0705
2024-0903
2024-1004
2024-1101
2024-1201
2025-0302
2025-0502
2025-0602
2025-0702
2025-0801.5
2025-0901.5
2025-1002
2025-1101.5
2025-1202
2026-0101
2026-0302
2026-0401.67
2026-0502
This device (reports/month)Average device in PBX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K143554 — cites (transitively): K090221 (d1), K111670 (d1), K083538 (d2), K100586 (d2), K083461 (d3) — cited as predicate by K152790, K161199, K171052, K182094, K190743, K191528, K202780, K212561

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

Manufacturer compliance record — Venus Concept Inc.

  • VAI 2020-01-16 Venus Concept Inc · 2 citations
  • VAI 2020-01-16 Venus Concept Inc · 2 citations
  • VAI 2017-05-02 Venus Concept Inc · 2 citations
  • VAI 2017-05-02 Venus Concept Inc · 2 citations
  • VAI 2014-04-22 Venus Concept Inc · 3 citations
  • VAI 2014-04-22 Venus Concept Inc · 3 citations