Cleared Traditional

Visualase MRI-Guided Laser Ablation System (SW 3.4)

K211269 · Medtronic Navigation, Inc. · Neurology

Jan 2022

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K211269 is an FDA 510(k) clearance for the Visualase MRI-Guided Laser Ablation System (SW 3.4), a Neurosurgical Laser With Mr Thermography (Class II — Special Controls, product code ONO), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on January 7, 2022, 255 days after receiving the submission on April 27, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K211269 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 2021
Decision Date	January 07, 2022
Days to Decision	255 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.