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FDA 510(k)

INFINI RADIOFREQUENCY SYSTEM

K-Number: K121481 · 2013-06-25

ApplicantLutronic Corporation
Decision Date2013-06-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INFINI 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 2013-06-25 under 510(k) number K121481. 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 INFINI RADIOFREQUENCY SYSTEM?

INFINI RADIOFREQUENCY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Lutronic Corporation. The 510(k) number is K121481.

When did INFINI RADIOFREQUENCY SYSTEM receive FDA 510(k) clearance?

INFINI RADIOFREQUENCY SYSTEM received FDA 510(k) clearance on 2013-06-25, under 510(k) number K121481.

Who is the listed applicant for INFINI 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 INFINI RADIOFREQUENCY SYSTEM?

The FDA product code for INFINI 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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