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BODY LASER APPLICATOR SERVICE PACK, Bliss

Model SPK160000 · VENUS CONCEPT LTD · DI 07290016541564

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 2026-09-12 · 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/device2019-02: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2/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 2.5/device2021-12: 0 reports for this device; peer average 2/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/device2022-08: 0 reports for this device; peer average 2/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 2.25/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 1.33/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.67/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 1.6/device2026-05: 0 reports for this device; peer average 2/device01020410031005060712050607081202030511120102030506070910111203050607080910111201030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0202
2019-0401.5
2019-1001
2020-0302
2020-1001
2021-0501
2021-0601
2021-0702.5
2021-1202
2022-0501
2022-0606
2022-0704
2022-0802
2022-1201
2023-0201
2023-0301
2023-0501
2023-1101
2023-1202
2024-0103
2024-0202
2024-0302.25
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
2025-0901.33
2025-1002
2025-1101.67
2025-1202
2026-0101
2026-0302
2026-0401.6
2026-0502
This device (reports/month)Average device in PBX, PKT (reports/device/month)

Regulatory clearances

  • K190743 SESE 2019-06-25 (k number procode)

Predicate lineage

K190743 — cites (transitively): K143554 (d1), K160470 (d1), K090221 (d2), K111670 (d2), K150230 (d2), K150724 (d2), K151179 (d2), K083538 (d3), K100586 (d3), K083795 (d3), K123971 (d3), K133212 (d3), DEN090002 (d3), K120023 (d3), K142491 (d3), K083461 (d4), K083595 (d4), K100230 (d4), K080521 (d4), K083629 (d5) — cited as predicate by K213308, K233904, K233962

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