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FDA 510(k)

LUTRONIC GENIUS Radiofrequency System

K-Number: K180945 · 2018-12-10

ApplicantLutronic Corporation
Decision Date2018-12-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUTRONIC GENIUS Radiofrequency System is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2018-12-10 under approval number K180945. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUTRONIC GENIUS Radiofrequency System?

LUTRONIC GENIUS Radiofrequency System is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Lutronic Corporation. The 510(k) number is K180945.

When was LUTRONIC GENIUS Radiofrequency System approved by the FDA?

LUTRONIC GENIUS Radiofrequency System received FDA 510(k) clearance on 2018-12-10, under approval number K180945.

What company makes LUTRONIC GENIUS Radiofrequency System?

LUTRONIC GENIUS Radiofrequency System is manufactured by Lutronic Corporation.

What is the FDA product code for LUTRONIC GENIUS Radiofrequency System?

The FDA product code for LUTRONIC GENIUS Radiofrequency System is GEI.

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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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