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., Monteris Medical, and Medtronic Navigation.
FDA 510(k) Cleared Neurosurgical Laser With Mr Thermography Devices (Product Code ONO)
About Product Code ONO - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code ONO since 2022, with 7 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ONO have taken an average of 101 days to reach a decision - down from 261 days historically, suggesting improved FDA processing for this classification.
ONO devices are reviewed by the Neurology panel. Browse all Neurology devices →