Cleared Traditional

K211269 - Visualase MRI-Guided Laser Ablation System (SW 3.4) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211269 · Medtronic Navigation, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
255d
Days
Class 2
Risk

K211269 is an FDA 510(k) clearance for the Visualase MRI-Guided Laser Ablation System (SW 3.4). Classified as Neurosurgical Laser With Mr Thermography (product code ONO), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on January 7, 2022 after a review of 255 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 878.4810 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Navigation, Inc. devices

Submission Details

510(k) Number K211269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 148d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONO Neurosurgical Laser With Mr Thermography
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - ONO Neurosurgical Laser With Mr Thermography

Devices cleared under the same product code (ONO) and FDA review panel - the closest regulatory comparables to K211269.
NeuroBlate System
K260976 · Monteris Medical, · Apr 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · Medtronic Navigation, Inc. · Mar 2026
Mobile Laser Unit (1001-N2)
K251298 · Clinical Laserthermia Systems, AB · Sep 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · Medtronic Navigation · May 2025
Monteris Medical NeuroBlate System
K240877 · Monteris Medical, · Jun 2024