FDA 510(k) Applications for Medical Device Product Code "ONO"
(Neurosurgical Laser With Mr Thermography)

FDA 510(k) Number Applicant Device Name Decision Date
K214125 Clinical Laserthermia Systems AB TRANBERG Thermoguide Therapy System 09/22/2022
K250307 Medtronic Navigation Visualase V2 MRI-guided Laser Ablation System (9736422) 05/29/2025
K211269 Medtronic Navigation, Inc. Visualase MRI-Guided Laser Ablation System (SW 3.4) 01/07/2022
K240877 Monteris Medical Monteris Medical NeuroBlate System 06/04/2024


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact