LLD
Model FS70007 · FORMATK SYSTEMS LTD · DI 07290016681345
GEX — Powered Laser Surgical Instrument · Class II · 21 CFR 878.4810
UDILibrary device dossier · generated 2026-09-14 · 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 | 6.66 |
| 2019-02 | 0 | 7.13 |
| 2019-03 | 0 | 7.97 |
| 2019-04 | 0 | 5.74 |
| 2019-05 | 0 | 5.67 |
| 2019-06 | 0 | 8.04 |
| 2019-07 | 0 | 5.59 |
| 2019-08 | 0 | 7.54 |
| 2019-09 | 0 | 6.99 |
| 2019-10 | 0 | 8.39 |
| 2019-11 | 0 | 6.91 |
| 2019-12 | 0 | 7.31 |
| 2020-01 | 0 | 6.52 |
| 2020-02 | 0 | 7.04 |
| 2020-03 | 0 | 9.95 |
| 2020-04 | 0 | 5.93 |
| 2020-05 | 0 | 6.07 |
| 2020-06 | 0 | 5.62 |
| 2020-07 | 0 | 6.73 |
| 2020-08 | 0 | 5.26 |
| 2020-09 | 0 | 5.6 |
| 2020-10 | 0 | 5.04 |
| 2020-11 | 0 | 4.8 |
| 2020-12 | 0 | 7.4 |
| 2021-01 | 0 | 8.38 |
| 2021-02 | 0 | 9.28 |
| 2021-03 | 0 | 7.87 |
| 2021-04 | 0 | 5.99 |
| 2021-05 | 0 | 8.19 |
| 2021-06 | 0 | 7.39 |
| 2021-07 | 0 | 8.33 |
| 2021-08 | 0 | 7.46 |
| 2021-09 | 0 | 6.11 |
| 2021-10 | 0 | 6.91 |
| 2021-11 | 0 | 7.38 |
| 2021-12 | 0 | 5.17 |
| 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 | 5.5 |
| 2022-09 | 0 | 4.09 |
| 2022-10 | 0 | 6.06 |
| 2022-11 | 0 | 4.47 |
| 2022-12 | 0 | 5.1 |
| 2023-01 | 0 | 5.09 |
| 2023-02 | 0 | 6.14 |
| 2023-03 | 0 | 6.03 |
| 2023-04 | 0 | 4.95 |
| 2023-05 | 0 | 5.49 |
| 2023-06 | 0 | 4.37 |
| 2023-07 | 0 | 4.92 |
| 2023-08 | 0 | 4.69 |
| 2023-09 | 0 | 3.65 |
| 2023-10 | 0 | 4.81 |
| 2023-11 | 0 | 4.25 |
| 2023-12 | 0 | 3.8 |
| 2024-01 | 0 | 3.49 |
| 2024-02 | 0 | 4.41 |
| 2024-03 | 0 | 4.81 |
| 2024-04 | 0 | 4 |
| 2024-05 | 0 | 4.71 |
| 2024-06 | 0 | 4.45 |
| 2024-07 | 0 | 4.09 |
| 2024-08 | 0 | 5.4 |
| 2024-09 | 0 | 4.33 |
| 2024-10 | 0 | 4.81 |
| 2024-11 | 0 | 4.68 |
| 2024-12 | 0 | 4.78 |
| 2025-01 | 0 | 4.69 |
| 2025-02 | 0 | 4.79 |
| 2025-03 | 0 | 6.2 |
| 2025-04 | 0 | 5.89 |
| 2025-05 | 0 | 4.82 |
| 2025-06 | 0 | 5.66 |
| 2025-07 | 0 | 5.72 |
| 2025-08 | 0 | 6.41 |
| 2025-09 | 0 | 5.18 |
| 2025-10 | 0 | 5.43 |
| 2025-11 | 0 | 5 |
| 2025-12 | 0 | 5.44 |
| 2026-01 | 0 | 5.92 |
| 2026-02 | 0 | 5.83 |
| 2026-03 | 0 | 5.24 |
| 2026-04 | 0 | 5.51 |
| 2026-05 | 0 | 5.78 |
| 2026-06 | 0 | 6.56 |
Regulatory clearances
- K153566 SESE 2016-04-06 (k number procode)
Predicate lineage
K153566 — cites (transitively): K142860 (d1), K151947 (d1), K040081 (d2), K043173 (d2), K060448 (d2), K063074 (d2), K083733 (d2), K130028 (d2), K053628 (d2), K091420 (d3), K110907 (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) — cited as predicate by K162781, K183307
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FORMATK SYSTEMS LTD
Nothing in the loaded window.