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COMEG MEDICAL
Model SOURCE LED SOPRO 281 BLANC · SOPRO · DI M430S28100021
NTN — Led Light Source · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-10 · 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)
2019-12
0
2
2020-01
0
2
2020-04
0
6
2020-05
0
11
2020-06
0
17.33
2020-07
0
16.25
2020-08
0
16.67
2020-09
0
32.5
2020-10
0
24
2020-11
0
19
2020-12
0
25.25
2021-01
0
23.33
2021-02
0
28
2021-03
0
18
2021-04
0
17.8
2021-05
0
17
2021-06
0
19.67
2021-07
0
23.33
2021-08
0
14.75
2021-09
0
20.25
2021-10
0
11
2021-11
0
16.75
2021-12
0
27.33
2022-01
0
19.33
2022-02
0
12.8
2022-03
0
19
2022-04
0
35
2022-05
0
25
2022-06
0
17.5
2022-07
0
21
2022-08
0
11
2022-09
0
12.67
2022-10
0
14
2022-11
0
10.25
2022-12
0
12
2023-01
0
10
2023-02
0
10.25
2023-03
0
11.75
2023-04
0
11
2023-05
0
8.6
2023-06
0
6.29
2023-07
0
11.29
2023-08
0
13.71
2023-09
0
9.63
2023-10
0
10.13
2023-11
0
13.38
2023-12
0
15.14
2024-01
0
15.86
2024-02
0
14.38
2024-03
0
14.57
2024-04
0
14
2024-05
0
10.5
2024-06
0
13.38
2024-07
0
15.29
2024-08
0
12
2024-09
0
15.14
2024-10
0
13.55
2024-11
0
8.33
2024-12
0
4.86
2025-01
0
4.67
2025-02
0
4.71
2025-03
0
4.4
2025-04
0
7.17
2025-05
0
5.86
2025-06
0
4.57
2025-07
0
3.9
2025-08
0
5.17
2025-09
0
2.63
2025-10
0
6.25
2025-11
0
15.43
2025-12
0
40.13
2026-01
0
37.17
2026-02
0
11.11
2026-03
0
16.89
2026-04
0
24.5
2026-05
0
17.8
2026-06
0
20.7
This device (reports/month)Average device in 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).