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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 the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2018-12-10 under 510(k) 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. The listed applicant is Lutronic Corporation. The 510(k) number is K180945.

When did LUTRONIC GENIUS Radiofrequency System receive FDA 510(k) clearance?

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

Who is the listed applicant for LUTRONIC GENIUS Radiofrequency System?

The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.

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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