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Panels › General, Plastic Surgery › Product code ONO · Class 2

Neurosurgical Laser With Mr Thermography

Regulation 878.4810

3510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Get daily alerts for ONOSample briefCSV

Top companies in ONO

Company510(k)sRecalls
Medtronic Navigation31
Monteris Medical30
Clinical Laserthermia Systems, AB20
Decided510(k)Device and applicantCode
Sep 3, 2026K262315NeuroBlate System
Monteris Medical
ONO
Apr 23, 2026K260976NeuroBlate System
Monteris Medical
ONO
Mar 13, 2026K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled
Medtronic Navigation, Inc.
ONO
Sep 4, 2025K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introdu
Clinical Laserthermia Systems, AB, SE
ONO
May 29, 2025K250307Visualase V2 MRI-guided Laser Ablation System (9736422)
Medtronic Navigation
ONO
Jun 4, 2024K240877Monteris Medical NeuroBlate System
Monteris Medical,
ONO
Sep 22, 2022K214125TRANBERG Thermoguide Therapy System
Clinical Laserthermia Systems, AB, SE
ONO
Jan 7, 2022K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)
Medtronic Navigation, Inc.
ONO

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