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Internal, CO2RE Intima
Model AS89732US · SYNERON MEDICAL LTD · DI 07290109950372
GEX — Powered Laser Surgical Instrument · 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.
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
7.13
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
This device (reports/month)Average device in GEX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K181523 — cites (transitively): K151655 (d1), K101321 (d2), K103501 (d2), K072182 (d3), K080463 (d3) — cited as predicate by K210847
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SYNERON MEDICAL LTD