Cleared Special

Visualase Thermal Therapy System

K181859 · Medtronic Navigation, Inc. · Neurology
Mar 2019
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K181859 is an FDA 510(k) clearance for the Visualase Thermal Therapy System, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on March 6, 2019, 237 days after receiving the submission on July 12, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K181859 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2018
Decision Date March 06, 2019
Days to Decision 237 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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