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COMEG MEDICAL TECHNOLOGIES
Model SOPRO 281 LIGHT SOURCE · SOPRO · DI 03760278260861
FCW — Light Source, Fiberoptic, Routine · Class II · 21 CFR 876.1500
NTN — Led Light Source · Class II · 21 CFR 876.1500
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.
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
1
2019-02
0
1
2019-03
0
1
2019-04
0
1.67
2019-05
0
1.2
2019-06
0
1.75
2019-07
0
4
2019-08
0
1.8
2019-09
0
2.67
2019-10
0
4.5
2019-11
0
6.5
2019-12
0
2.25
2020-01
0
3.5
2020-02
0
1
2020-03
0
2.67
2020-04
0
2.5
2020-05
0
10
2020-06
0
8.71
2020-07
0
9
2020-08
0
10.8
2020-09
0
17
2020-10
0
13.88
2020-11
0
11.29
2020-12
0
13.25
2021-01
0
18
2021-02
0
11.5
2021-03
0
15.2
2021-04
0
13.14
2021-05
0
12.57
2021-06
0
11.67
2021-07
0
12.33
2021-08
0
11
2021-09
0
14.17
2021-10
0
7
2021-11
0
7
2021-12
0
12.43
2022-01
0
13.2
2022-02
0
8.22
2022-03
0
15.86
2022-04
0
15.86
2022-05
0
15.45
2022-06
0
10.62
2022-07
0
13.6
2022-08
0
6.5
2022-09
0
10.6
2022-10
0
10.5
2022-11
0
7.25
2022-12
0
8.75
2023-01
0
7
2023-02
0
6.1
2023-03
0
6.3
2023-04
0
6
2023-05
0
6.36
2023-06
0
5
2023-07
0
9.7
2023-08
0
12.44
2023-09
0
9.36
2023-10
0
8.33
2023-11
0
12.27
2023-12
0
9.58
2024-01
0
14.56
2024-02
0
10.58
2024-03
0
11.27
2024-04
0
12.6
2024-05
0
8
2024-06
0
10.58
2024-07
0
13.2
2024-08
0
10.93
2024-09
0
11.9
2024-10
0
10.67
2024-11
0
6.15
2024-12
0
4.64
2025-01
0
4.33
2025-02
0
4.92
2025-03
0
4.87
2025-04
0
6.88
2025-05
0
7.5
2025-06
0
4.9
2025-07
0
6
2025-08
0
7.63
2025-09
0
3.85
2025-10
0
5.45
2025-11
0
12.8
2025-12
0
23.64
2026-01
0
19.38
2026-02
0
8.13
2026-03
0
16.45
2026-04
0
19.44
2026-05
0
11.59
2026-06
0
12.89
This device (reports/month)Average device in FCW, NTN (reports/device/month)
Regulatory clearances
K103813 SESE 2011-03-22 (k number procode)
Predicate lineage
K103813 — cites (transitively): K093792 (d1), K102167 (d1) — cited as predicate by K131226
Lineage extracted from public 510(k) summary text (heuristic).