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 a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2019-03-06 under approval 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. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K181859.
When was Visualase Thermal Therapy System approved by the FDA?
Visualase Thermal Therapy System received FDA 510(k) clearance on 2019-03-06, under approval number K181859.
What company makes Visualase Thermal Therapy System?
Visualase Thermal Therapy System is manufactured by Medtronic Navigation, Inc..
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.