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
K211269 Medtronic Navigation, Inc. Visualase MRI-Guided Laser Ablation System (SW 3.4) 01/07/2022


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