ONO · Class II · 21 CFR 878.4810

FDA Product Code ONO: Neurosurgical Laser With Mr Thermography

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.

Leading manufacturers include Medtronic Navigation, Inc..

2
Total
2
Cleared
210d
Avg days
2022
Since

List of Neurosurgical Laser With Mr Thermography devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
K253391
Medtronic Navigation, Inc.
Neurology · 164d
Cleared Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269
Medtronic Navigation, Inc.
Neurology · 255d

How to use this database

This page lists all FDA 510(k) submissions for Neurosurgical Laser With Mr Thermography devices (product code ONO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →