Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
52 linked reportsInjury 52
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.58 |
| 2019-02 | 0 | 7.06 |
| 2019-03 | 0 | 7.6 |
| 2019-04 | 0 | 5.74 |
| 2019-05 | 0 | 5.7 |
| 2019-06 | 0 | 7.96 |
| 2019-07 | 0 | 5.54 |
| 2019-08 | 0 | 7.27 |
| 2019-09 | 0 | 6.86 |
| 2019-10 | 0 | 8.29 |
| 2019-11 | 0 | 6.84 |
| 2019-12 | 0 | 7.11 |
| 2020-01 | 0 | 6.49 |
| 2020-02 | 0 | 6.93 |
| 2020-03 | 0 | 9.6 |
| 2020-04 | 0 | 5.82 |
| 2020-05 | 0 | 6.07 |
| 2020-06 | 0 | 5.56 |
| 2020-07 | 0 | 6.66 |
| 2020-08 | 0 | 5.26 |
| 2020-09 | 0 | 5.57 |
| 2020-10 | 0 | 5.04 |
| 2020-11 | 0 | 4.8 |
| 2020-12 | 0 | 7.3 |
| 2021-01 | 0 | 7.81 |
| 2021-02 | 0 | 9.12 |
| 2021-03 | 0 | 7.87 |
| 2021-04 | 0 | 5.99 |
| 2021-05 | 0 | 8.19 |
| 2021-06 | 0 | 7.39 |
| 2021-07 | 0 | 7.95 |
| 2021-08 | 0 | 7.37 |
| 2021-09 | 0 | 6.03 |
| 2021-10 | 0 | 6.91 |
| 2021-11 | 0 | 7.26 |
| 2021-12 | 0 | 5.1 |
| 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 | 4.76 |
| 2022-08 | 0 | 5.41 |
| 2022-09 | 0 | 4.09 |
| 2022-10 | 0 | 6.06 |
| 2022-11 | 0 | 4.41 |
| 2022-12 | 0 | 5.1 |
| 2023-01 | 0 | 5 |
| 2023-02 | 0 | 6.14 |
| 2023-03 | 0 | 5.91 |
| 2023-04 | 0 | 4.66 |
| 2023-05 | 0 | 5.49 |
| 2023-06 | 0 | 4.33 |
| 2023-07 | 0 | 4.87 |
| 2023-08 | 0 | 4.69 |
| 2023-09 | 0 | 3.61 |
| 2023-10 | 0 | 4.7 |
| 2023-11 | 0 | 4.2 |
| 2023-12 | 0 | 3.71 |
| 2024-01 | 0 | 3.45 |
| 2024-02 | 0 | 4.34 |
| 2024-03 | 0 | 4.65 |
| 2024-04 | 0 | 3.97 |
| 2024-05 | 0 | 4.63 |
| 2024-06 | 0 | 4.36 |
| 2024-07 | 0 | 4.03 |
| 2024-08 | 0 | 5.4 |
| 2024-09 | 0 | 4.29 |
| 2024-10 | 0 | 4.81 |
| 2024-11 | 0 | 4.58 |
| 2024-12 | 0 | 4.58 |
| 2025-01 | 0 | 4.69 |
| 2025-02 | 4 | 4.77 |
| 2025-03 | 0 | 6.04 |
| 2025-04 | 2 | 5.59 |
| 2025-05 | 2 | 4.73 |
| 2025-06 | 0 | 5.45 |
| 2025-07 | 0 | 5.54 |
| 2025-08 | 0 | 6.29 |
| 2025-09 | 0 | 5.02 |
| 2025-10 | 4 | 5.32 |
| 2025-11 | 4 | 4.87 |
| 2025-12 | 0 | 5.38 |
| 2026-01 | 0 | 5.92 |
| 2026-02 | 12 | 5.95 |
| 2026-03 | 18 | 5.65 |
| 2026-04 | 0 | 5.4 |
| 2026-05 | 0 | 5.64 |
| 2026-06 | 6 | 6.54 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-23 | 3004167969-2026-00010 | Injury | Available | catalog number |
| 2026-06-18 | 3004450661-2026-00010 | Injury | Available | catalog number |
| 2026-03-30 | 3004167969-2026-00007 | Injury | Available | catalog number |
| 2026-03-26 | 3004450661-2026-00006 | Injury | Available | catalog number |
| 2026-03-26 | 3004450661-2026-00007 | Injury | Available | catalog number |
| 2026-03-26 | 3004167969-2026-00006 | Injury | Available | catalog number |
| 2026-03-24 | 3004167969-2026-00005 | Injury | Available | catalog number |
| 2026-03-20 | 3004450661-2026-00005 | Injury | Available | catalog number |
| 2026-02-19 | 3004450661-2026-00004 | Injury | Available | catalog number |
| 2026-02-19 | 3004167969-2026-00004 | Injury | Available | catalog number |
| 2026-02-11 | 3004167969-2026-00002 | Injury | Available | catalog number |
| 2026-02-09 | 3004450661-2026-00002 | Injury | Available | catalog number |
| 2025-11-17 | 3004167969-2025-00022 | Injury | Available | catalog number |
| 2025-11-13 | 3004450661-2025-00022 | Injury | Available | catalog number |
| 2025-10-22 | 3004167969-2025-00021 | Injury | Available | catalog number |
Showing the most recent 20 of 52 linked reports.
Showing 1–15 of 20
Regulatory clearances
- 510(k)K230308Substantially equivalent (SESE) · 2023-03-01clearance family
Predicate lineage
- K230308
Cited as predicate by: K233024
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2013-12-11 | NAI | No action indicated | Alma Lasers, Inc. | 0 |
| 2013-12-11 | NAI | No action indicated | Alma Lasers, Inc. | 0 |
| 2013-06-07 | WL | Warning Letter | Alma Lasers, Inc. | — |
| 2013-06-07 | WL | Warning Letter | Alma Lasers, Inc. | — |
| 2013-01-29 | OAI | Official action indicated | Alma Lasers, Inc. | 0 |
| 2013-01-29 | OAI | Official action indicated | Alma Lasers, Inc. | 0 |
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