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FemiLift Slim Sleeve
Model 1 · ALMA LASERS LTD. · DI 17290110122017
GEX — Powered Laser Surgical Instrument · Class II · 21 CFR 878.4810
HQF — Laser, Ophthalmic · Class II · 21 CFR 886.4390
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
6.66
2019-02
0
7.04
2019-03
0
7.85
2019-04
0
5.57
2019-05
0
5.6
2019-06
0
8.04
2019-07
0
5.52
2019-08
0
7.54
2019-09
0
6.9
2019-10
0
8.39
2019-11
0
6.91
2019-12
0
7.2
2020-01
0
6.38
2020-02
0
6.97
2020-03
0
9.57
2020-04
0
5.77
2020-05
0
5.73
2020-06
0
5.48
2020-07
0
6.73
2020-08
0
5.19
2020-09
0
5.51
2020-10
0
4.94
2020-11
0
4.8
2020-12
0
7.4
2021-01
0
8.23
2021-02
0
9.28
2021-03
0
7.68
2021-04
0
5.86
2021-05
0
7.95
2021-06
0
7.19
2021-07
0
8.19
2021-08
0
7.35
2021-09
0
5.88
2021-10
0
6.81
2021-11
0
7.04
2021-12
0
5.03
2022-01
0
4.09
2022-02
0
5.47
2022-03
0
4.39
2022-04
0
6.62
2022-05
0
4.9
2022-06
0
4.64
2022-07
0
4.63
2022-08
0
5.13
2022-09
0
4.03
2022-10
0
5.82
2022-11
0
4.43
2022-12
0
4.9
2023-01
0
4.81
2023-02
0
5.71
2023-03
0
5.82
2023-04
0
4.87
2023-05
0
5.48
2023-06
0
4.2
2023-07
0
4.79
2023-08
0
4.45
2023-09
0
3.47
2023-10
0
4.54
2023-11
0
4.07
2023-12
0
3.59
2024-01
0
3.44
2024-02
0
4.17
2024-03
0
4.63
2024-04
0
3.94
2024-05
0
4.53
2024-06
0
4.29
2024-07
0
3.95
2024-08
0
5.25
2024-09
0
4.23
2024-10
0
4.74
2024-11
0
4.63
2024-12
0
4.71
2025-01
0
4.47
2025-02
0
4.74
2025-03
0
5.91
2025-04
0
5.74
2025-05
0
4.61
2025-06
0
5.27
2025-07
0
5.51
2025-08
0
6.17
2025-09
0
5
2025-10
0
5.31
2025-11
0
4.76
2025-12
0
5.18
2026-01
0
5.92
2026-02
0
5.83
2026-03
0
4.88
2026-04
0
5.45
2026-05
0
5.66
2026-06
0
6.32
This device (reports/month)Average device in GEX, HQF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K103501 — cites (transitively): K080463 (d1) — cited as predicate by K141658, K151655, K182270, K203441, K250071, K251230
Lineage extracted from public 510(k) summary text (heuristic).