Neurosurgical Laser With Mr Thermography
General, Plastic Surgery · 21 CFR 878.4810
Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.
Recent MDR events
1 adverse event reports on file
Registered firms
14 firms currently registered for this product code
Isomedix Operations, Inc.
Minneapolis, MN, US
Monteris Medical Corp
Minnetonka, MN, US
Medtronic Navigation, Inc.
Lafayette, CO, US
Steril Verona S.r.l.
ERBE Verona, IT
Medtronic Xomed, Inc.
Jacksonville, FL, US
Clinical Laserthermia Systems Ab
Lund Skane, SE
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
510(k) clearances
7 clearances for this product code
- Monteris MedicalApr 23, 2026
K260976 · NeuroBlate System
- Medtronic Navigation, Inc.Mar 13, 2026
K253391 · Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
- Clinical Laserthermia Systems, ABSep 4, 2025
K251298 · Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
- Medtronic NavigationMay 29, 2025
K250307 · Visualase V2 MRI-guided Laser Ablation System (9736422)
- Monteris Medical,Jun 4, 2024
K240877 · Monteris Medical NeuroBlate System
- Clinical Laserthermia Systems, ABSep 22, 2022
K214125 · TRANBERG Thermoguide Therapy System
- Medtronic Navigation, Inc.Jan 7, 2022
K211269 · Visualase MRI-Guided Laser Ablation System (SW 3.4)