Alpha
Model FS90000 · FORMATK SYSTEMS LTD · DI 07290016681062
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
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.58 |
| 2019-02 | 0 | 7.06 |
| 2019-03 | 0 | 7.9 |
| 2019-04 | 0 | 5.74 |
| 2019-05 | 0 | 5.7 |
| 2019-06 | 0 | 7.96 |
| 2019-07 | 0 | 5.59 |
| 2019-08 | 0 | 7.27 |
| 2019-09 | 0 | 6.86 |
| 2019-10 | 0 | 8.39 |
| 2019-11 | 0 | 6.84 |
| 2019-12 | 0 | 7.11 |
| 2020-01 | 0 | 6.49 |
| 2020-02 | 0 | 7 |
| 2020-03 | 0 | 9.83 |
| 2020-04 | 0 | 5.89 |
| 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 | 8.07 |
| 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 | 5.09 |
| 2023-02 | 0 | 6.14 |
| 2023-03 | 0 | 5.97 |
| 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 | 3.75 |
| 2024-01 | 0 | 3.45 |
| 2024-02 | 0 | 4.34 |
| 2024-03 | 0 | 4.74 |
| 2024-04 | 0 | 3.97 |
| 2024-05 | 0 | 4.68 |
| 2024-06 | 0 | 4.39 |
| 2024-07 | 0 | 4.03 |
| 2024-08 | 0 | 5.4 |
| 2024-09 | 0 | 4.29 |
| 2024-10 | 0 | 4.81 |
| 2024-11 | 0 | 4.65 |
| 2024-12 | 0 | 4.78 |
| 2025-01 | 0 | 4.69 |
| 2025-02 | 0 | 4.78 |
| 2025-03 | 0 | 6.2 |
| 2025-04 | 0 | 5.74 |
| 2025-05 | 0 | 4.77 |
| 2025-06 | 0 | 5.5 |
| 2025-07 | 0 | 5.66 |
| 2025-08 | 0 | 6.29 |
| 2025-09 | 0 | 5.13 |
| 2025-10 | 0 | 5.4 |
| 2025-11 | 0 | 4.89 |
| 2025-12 | 0 | 5.38 |
| 2026-01 | 0 | 5.92 |
| 2026-02 | 0 | 5.86 |
| 2026-03 | 0 | 5.43 |
| 2026-04 | 0 | 5.4 |
| 2026-05 | 0 | 5.64 |
| 2026-06 | 0 | 6.54 |
Regulatory clearances
- K183307 SESE 2018-12-11 (k number procode)
Predicate lineage
K183307 — cites (transitively): K020839 (d1), K153566 (d1), K170060 (d1), K142860 (d2), K151947 (d2), K130028 (d2), K083733 (d3), K091420 (d3), K110907 (d3), K040081 (d3), K043173 (d3), K060448 (d3), K063074 (d3), K053628 (d3), K033549 (d4), K041086 (d4), K070298 (d4), K101506 (d4), K060301 (d5), K063571 (d5), K071152 (d5), K071768 (d5), K073583 (d5), K080244 (d5), K083900 (d5), K090195 (d5), K091446 (d5), K100270 (d5)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FORMATK SYSTEMS LTD
Nothing in the loaded window.