Cleared Traditional

Visualase V2 MRI-guided Laser Ablation System (9736422)

K250307 · Medtronic Navigation · Neurology

May 2025

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K250307 is an FDA 510(k) clearance for the Visualase V2 MRI-guided Laser Ablation System (9736422), a Neurosurgical Laser With Mr Thermography (Class II — Special Controls, product code ONO), submitted by Medtronic Navigation (Lafayette, US). The FDA issued a Cleared decision on May 29, 2025, 115 days after receiving the submission on February 3, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K250307 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2025
Decision Date	May 29, 2025
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	ONO — Neurosurgical Laser With Mr Thermography
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	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.