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FDA 510(k)

Electrodes Handpieces for Mygen V-1000 RF System

K-Number: K193355 · 2020-08-03

ApplicantRF Medical Co., Ltd.
Decision Date2020-08-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrodes Handpieces for Mygen V-1000 RF System is a medical device manufactured by RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-08-03 under approval number K193355. 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 Electrodes Handpieces for Mygen V-1000 RF System?

Electrodes Handpieces for Mygen V-1000 RF System is a medical device that received FDA 510(k) clearance on 2020-08-03. It is manufactured by RF Medical Co., Ltd.. The 510(k) number is K193355.

When was Electrodes Handpieces for Mygen V-1000 RF System approved by the FDA?

Electrodes Handpieces for Mygen V-1000 RF System received FDA 510(k) clearance on 2020-08-03, under approval number K193355.

What company makes Electrodes Handpieces for Mygen V-1000 RF System?

Electrodes Handpieces for Mygen V-1000 RF System is manufactured by RF Medical Co., Ltd..

What is the FDA product code for Electrodes Handpieces for Mygen V-1000 RF System?

The FDA product code for Electrodes Handpieces for Mygen V-1000 RF System is GEI.

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Other Devices by RF Medical Co., Ltd.

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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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