Cleared Traditional

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

K253391 · Medtronic Navigation, Inc. · Neurology

Mar 2026

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K253391 is an FDA 510(k) clearance for the Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561), a Neurosurgical Laser With Mr Thermography (Class II — Special Controls, product code ONO), submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on March 13, 2026, 164 days after receiving the submission on September 30, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K253391 FDA.gov
FDA Decision	Cleared 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

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.