LB2 + LF2 kit
Model PK000039 · VENUS CONCEPT LTD · DI 07290016540062
GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.78 |
| 2019-02 | 0 | 4.35 |
| 2019-03 | 0 | 4.42 |
| 2019-04 | 0 | 6.06 |
| 2019-05 | 0 | 4.8 |
| 2019-06 | 0 | 5.04 |
| 2019-07 | 0 | 5.86 |
| 2019-08 | 0 | 6.1 |
| 2019-09 | 0 | 4.99 |
| 2019-10 | 0 | 5.83 |
| 2019-11 | 0 | 5.62 |
| 2019-12 | 0 | 5.41 |
| 2020-01 | 0 | 4.81 |
| 2020-02 | 0 | 5.57 |
| 2020-03 | 0 | 5.68 |
| 2020-04 | 0 | 3.57 |
| 2020-05 | 0 | 3.76 |
| 2020-06 | 0 | 5.14 |
| 2020-07 | 0 | 6.56 |
| 2020-08 | 0 | 4.64 |
| 2020-09 | 0 | 5.86 |
| 2020-10 | 0 | 5.52 |
| 2020-11 | 0 | 5.14 |
| 2020-12 | 0 | 5.31 |
| 2021-01 | 0 | 5.17 |
| 2021-02 | 0 | 4.89 |
| 2021-03 | 0 | 5.7 |
| 2021-04 | 0 | 5.26 |
| 2021-05 | 0 | 5.12 |
| 2021-06 | 0 | 5.77 |
| 2021-07 | 0 | 4.86 |
| 2021-08 | 0 | 4.3 |
| 2021-09 | 0 | 4.77 |
| 2021-10 | 0 | 6.17 |
| 2021-11 | 0 | 5.57 |
| 2021-12 | 0 | 5.56 |
| 2022-01 | 0 | 5.04 |
| 2022-02 | 0 | 5.15 |
| 2022-03 | 0 | 5.75 |
| 2022-04 | 0 | 4.98 |
| 2022-05 | 0 | 5.75 |
| 2022-06 | 0 | 6.3 |
| 2022-07 | 0 | 4.36 |
| 2022-08 | 0 | 4.59 |
| 2022-09 | 0 | 5 |
| 2022-10 | 0 | 4.76 |
| 2022-11 | 0 | 4.61 |
| 2022-12 | 0 | 4.02 |
| 2023-01 | 0 | 5.52 |
| 2023-02 | 0 | 4.57 |
| 2023-03 | 0 | 4.85 |
| 2023-04 | 0 | 4.78 |
| 2023-05 | 0 | 5.11 |
| 2023-06 | 0 | 4.78 |
| 2023-07 | 0 | 4.82 |
| 2023-08 | 0 | 4.44 |
| 2023-09 | 0 | 5.23 |
| 2023-10 | 0 | 5.1 |
| 2023-11 | 0 | 4.36 |
| 2023-12 | 0 | 4.77 |
| 2024-01 | 0 | 5.52 |
| 2024-02 | 0 | 5.44 |
| 2024-03 | 0 | 6.13 |
| 2024-04 | 0 | 6.04 |
| 2024-05 | 0 | 6.25 |
| 2024-06 | 0 | 5.36 |
| 2024-07 | 0 | 5.05 |
| 2024-08 | 0 | 5.01 |
| 2024-09 | 0 | 5.18 |
| 2024-10 | 0 | 5.69 |
| 2024-11 | 0 | 5.27 |
| 2024-12 | 0 | 4.04 |
| 2025-01 | 0 | 5.17 |
| 2025-02 | 0 | 4.46 |
| 2025-03 | 0 | 6.26 |
| 2025-04 | 0 | 4.39 |
| 2025-05 | 0 | 5.12 |
| 2025-06 | 0 | 5.05 |
| 2025-07 | 0 | 5.18 |
| 2025-08 | 0 | 5.41 |
| 2025-09 | 0 | 4.81 |
| 2025-10 | 0 | 5.12 |
| 2025-11 | 0 | 5.49 |
| 2025-12 | 0 | 5.79 |
| 2026-01 | 0 | 5.6 |
| 2026-02 | 0 | 5.98 |
| 2026-03 | 0 | 6.18 |
| 2026-04 | 0 | 5.36 |
| 2026-05 | 0 | 6.17 |
| 2026-06 | 0 | 5.56 |
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
K191528 — cites (transitively): K142910 (d1), K143554 (d1), K111670 (d2), K090221 (d2), K083538 (d3), K100586 (d3), K083461 (d4) — cited as predicate by K220592, K231092, K240178, K252845
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — VENUS CONCEPT LTD
- 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