FDA 510(k)

Mygen V-1000 RF System

K-Number: K180999 · 2018-12-11

Decision Date2018-12-11

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Mygen V-1000 RF System is a medical device manufactured by RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-12-11 under approval number K180999. 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 Mygen V-1000 RF System?

Mygen V-1000 RF System is a medical device that received FDA 510(k) clearance on 2018-12-11. It is manufactured by RF Medical Co., Ltd.. The 510(k) number is K180999.

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

Mygen V-1000 RF System received FDA 510(k) clearance on 2018-12-11, under approval number K180999.

What company makes Mygen V-1000 RF System?

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

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

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

Other Devices by RF Medical Co., Ltd.

K193355Electrodes Handpieces for Mygen V-1000 RF System K221277Mygen M-3004 RF Generator M-3004 K232763Electrode Handpieces (VCT, RFTV, BMDT series)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.