Model V6310-20CR · KATALYST SURGICAL LLC · DI 10817489023737
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)
2019-02
0
1
2019-03
0
1
2019-04
0
1
2019-05
0
1
2019-07
0
1
2019-09
0
1
2019-12
0
1
2020-01
0
1.5
2020-02
0
2
2020-03
0
1.33
2020-04
0
1.5
2020-05
0
1
2020-06
0
1
2020-08
0
1
2020-09
0
1
2020-10
0
1.5
2021-01
0
3
2021-03
0
2
2021-04
0
1
2021-05
0
1
2021-06
0
1
2021-07
0
1
2021-08
0
1
2021-09
0
1
2021-10
0
1
2021-11
0
1
2021-12
0
1
2022-01
0
2
2022-02
0
2.67
2022-05
0
4
2022-06
0
1.33
2022-07
0
1
2022-08
0
1.4
2022-09
0
2
2022-10
0
1.67
2022-11
0
2
2022-12
0
1
2023-01
0
1.75
2023-02
0
1.4
2023-03
0
1.33
2023-04
0
3.33
2023-05
0
5
2023-06
0
1.75
2023-07
0
2.33
2023-08
0
1
2023-09
0
1
2023-10
0
1
2023-11
0
1
2023-12
0
1.71
2024-01
0
2
2024-02
0
1.25
2024-03
0
1.33
2024-04
0
2
2024-05
0
2
2024-06
0
1.5
2024-07
0
1.33
2024-08
0
2.33
2024-09
0
1.5
2024-10
0
1
2024-11
0
2
2024-12
0
1
2025-01
0
1.33
2025-02
0
3
2025-03
0
1
2025-04
0
1.5
2025-05
0
1.25
2025-06
0
1
2025-07
0
1
2025-08
0
1.33
2025-09
0
1.33
2025-10
0
1.5
2025-11
0
1.25
2025-12
0
1.25
2026-03
0
1
2026-04
0
1
2026-05
0
1
2026-06
0
1
This device (reports/month)Average device in HQF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K121187 — cites (transitively): K050807 (d1) — cited as predicate by K140362, K142830, K182646
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — KATALYST SURGICAL LLC
VAI 2017-08-07 Katalyst Surgical, LLC · 2 citations
VAI 2017-08-07 Katalyst Surgical, LLC · 2 citations
VAI 2016-03-15 Katalyst Surgical, LLC · 6 citations
VAI 2016-03-15 Katalyst Surgical, LLC · 6 citations