Cleared Traditional

K253391 - Visualase Cooled Laser Applicator System (9735559) (FDA 510(k) Clearance)

Also includes:
Visualase Cooled Laser Applicator System (9735560) Visualase Cooled Laser Applicator System (9735561)

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

K253391 · Medtronic Navigation, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
164d
Days
Class 2
Risk

K253391 is an FDA 510(k) clearance for the Visualase Cooled Laser Applicator System (9735559). Classified as Neurosurgical Laser With Mr Thermography (product code ONO), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on March 13, 2026 after a review of 164 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 K253391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date March 13, 2026
Days to Decision 164 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
16d slower than avg
Panel avg: 148d · This submission: 164d
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 K253391.
NeuroBlate System
K260976 · Monteris Medical, · Apr 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
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · Medtronic Navigation, Inc. · Jan 2022