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Venus Bliss Max
Model BLMX0001 · Venus Concept Inc. · DI 00810060830987
NGX — Stimulator, Muscle, Powered, For Muscle Conditioning · Class II · 21 CFR 890.5850
PBX — Massager, Vacuum, Radio Frequency Induced Heat · Class II · 21 CFR 878.4400
PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use · Class II · 21 CFR 878.5400
UDILibrary device dossier · generated 2026-09-13 · 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 (5)
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.
Injury: 3 · Malfunction: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1
2019-02
0
2
2019-04
0
1.5
2019-10
0
1
2019-11
0
2
2020-03
0
2.5
2020-04
0
6
2020-10
0
1
2021-01
0
1.13
2021-05
0
1
2021-06
0
1
2021-07
0
2.5
2021-12
0
2
2022-02
0
6
2022-05
0
1
2022-06
0
6
2022-07
0
2.5
2022-08
0
2
2022-10
0
1
2022-12
0
1.5
2023-02
0
1
2023-03
0
1
2023-04
0
1
2023-05
0
1
2023-09
0
2
2023-11
0
1
2023-12
0
2
2024-01
0
3
2024-02
0
1.5
2024-03
0
2.4
2024-05
0
2
2024-06
0
1
2024-07
0
5
2024-09
0
3
2024-10
0
4
2024-11
0
1
2024-12
0
1
2025-03
0
2
2025-05
0
2
2025-06
0
1.67
2025-07
2
1.75
2025-08
0
2
2025-09
1
1.2
2025-10
0
3
2025-11
2
3.17
2025-12
0
1.57
2026-01
0
1
2026-02
0
1
2026-03
0
3.33
2026-04
0
1.5
2026-05
0
2
2026-06
0
4
This device (reports/month)Average device in NGX, PBX, PKT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Venus Concept Inc.