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FDA 510(k)

Visualase Thermal Therapy System

K-Number: K181859 · 2019-03-06

ApplicantMedtronic Navigation, Inc.
Decision Date2019-03-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Visualase Thermal Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2019-03-06 under 510(k) number K181859. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visualase Thermal Therapy System?

Visualase Thermal Therapy System is a medical device that received FDA 510(k) clearance on 2019-03-06. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K181859.

When did Visualase Thermal Therapy System receive FDA 510(k) clearance?

Visualase Thermal Therapy System received FDA 510(k) clearance on 2019-03-06, under 510(k) number K181859.

Who is the listed applicant for Visualase Thermal Therapy System?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visualase Thermal Therapy System?

The FDA product code for Visualase Thermal Therapy System is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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