"M22 IPL ""AC"" Filter"
Model NA · LUMENIS BE LTD · DI 07290117772218
GEX — Powered Laser Surgical Instrument · Class II · 21 CFR 878.4810
ONF — Powered Light Based Non-Laser Surgical Instrument With Thermal Effect · Class II · 21 CFR 878.4810
ONG — Powered Laser Surgical Instrument With MicrobeamFractional Output · Class II · 21 CFR 878.4810
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 (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 | 6.52 |
| 2019-02 | 0 | 6.9 |
| 2019-03 | 0 | 7.83 |
| 2019-04 | 0 | 5.74 |
| 2019-05 | 0 | 5.67 |
| 2019-06 | 0 | 7.89 |
| 2019-07 | 0 | 5.52 |
| 2019-08 | 0 | 7.13 |
| 2019-09 | 0 | 6.75 |
| 2019-10 | 0 | 8.39 |
| 2019-11 | 0 | 6.6 |
| 2019-12 | 0 | 6.92 |
| 2020-01 | 0 | 6.45 |
| 2020-02 | 0 | 6.79 |
| 2020-03 | 0 | 9.72 |
| 2020-04 | 0 | 5.86 |
| 2020-05 | 0 | 6.07 |
| 2020-06 | 0 | 5.51 |
| 2020-07 | 0 | 6.58 |
| 2020-08 | 0 | 5.26 |
| 2020-09 | 0 | 5.54 |
| 2020-10 | 0 | 5.04 |
| 2020-11 | 0 | 4.76 |
| 2020-12 | 0 | 7.2 |
| 2021-01 | 0 | 7.63 |
| 2021-02 | 0 | 8.96 |
| 2021-03 | 0 | 7.79 |
| 2021-04 | 0 | 5.92 |
| 2021-05 | 0 | 8.19 |
| 2021-06 | 0 | 7.39 |
| 2021-07 | 0 | 7.74 |
| 2021-08 | 0 | 7.28 |
| 2021-09 | 0 | 5.95 |
| 2021-10 | 0 | 6.91 |
| 2021-11 | 0 | 7.07 |
| 2021-12 | 0 | 5.03 |
| 2022-01 | 0 | 4.13 |
| 2022-02 | 0 | 5.61 |
| 2022-03 | 0 | 4.39 |
| 2022-04 | 0 | 6.62 |
| 2022-05 | 0 | 4.93 |
| 2022-06 | 0 | 4.79 |
| 2022-07 | 0 | 4.7 |
| 2022-08 | 0 | 5.25 |
| 2022-09 | 0 | 4.09 |
| 2022-10 | 0 | 6.06 |
| 2022-11 | 0 | 4.36 |
| 2022-12 | 0 | 5.1 |
| 2023-01 | 0 | 5.09 |
| 2023-02 | 0 | 6.14 |
| 2023-03 | 0 | 5.83 |
| 2023-04 | 0 | 4.54 |
| 2023-05 | 0 | 5.49 |
| 2023-06 | 0 | 4.29 |
| 2023-07 | 0 | 4.82 |
| 2023-08 | 0 | 4.63 |
| 2023-09 | 0 | 3.56 |
| 2023-10 | 0 | 4.61 |
| 2023-11 | 0 | 4.16 |
| 2023-12 | 0 | 3.67 |
| 2024-01 | 0 | 3.38 |
| 2024-02 | 0 | 4.27 |
| 2024-03 | 0 | 4.55 |
| 2024-04 | 0 | 3.94 |
| 2024-05 | 0 | 4.59 |
| 2024-06 | 0 | 4.34 |
| 2024-07 | 0 | 4.02 |
| 2024-08 | 0 | 5.32 |
| 2024-09 | 0 | 4.2 |
| 2024-10 | 0 | 4.81 |
| 2024-11 | 0 | 4.55 |
| 2024-12 | 0 | 4.78 |
| 2025-01 | 0 | 4.69 |
| 2025-02 | 0 | 4.74 |
| 2025-03 | 0 | 6.19 |
| 2025-04 | 0 | 5.74 |
| 2025-05 | 0 | 4.77 |
| 2025-06 | 0 | 5.41 |
| 2025-07 | 0 | 5.61 |
| 2025-08 | 0 | 6.09 |
| 2025-09 | 0 | 5.1 |
| 2025-10 | 0 | 5.41 |
| 2025-11 | 0 | 4.79 |
| 2025-12 | 0 | 5.28 |
| 2026-01 | 0 | 5.92 |
| 2026-02 | 0 | 5.78 |
| 2026-03 | 0 | 5.39 |
| 2026-04 | 0 | 5.3 |
| 2026-05 | 0 | 5.46 |
| 2026-06 | 0 | 6.47 |
Regulatory clearances
- K170060 SESE 2017-08-09 (k number procode)
Predicate lineage
K170060 — cites (transitively): K020839 (d1), K130028 (d1), K142860 (d1), K083733 (d2), K091420 (d2), K110907 (d2), K040081 (d2), K043173 (d2), K060448 (d2), K063074 (d2), K033549 (d3), K041086 (d3), K070298 (d3), K101506 (d3), K060301 (d4), K063571 (d4), K071152 (d4), K071768 (d4), K073583 (d4), K080244 (d4), K083900 (d4), K090195 (d4), K091446 (d4), K100270 (d4) — cited as predicate by K183307, K192350, K193500, K200616, K203441
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LUMENIS BE LTD
- NAI 2018-10-30 Lumenis, Inc. · 0 citations
- VAI 2016-09-13 Lumenis, Inc. · 2 citations
- NAI 2013-03-15 Lumenis, Inc. · 0 citations