FDA 510(k)

RFMagik Lite

K-Number: K242469 · 2025-04-25

Decision Date2025-04-25

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RFMagik Lite is a medical device manufactured by Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under approval number K242469. 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 RFMagik Lite?

RFMagik Lite is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Agnes Medical Co., Ltd.. The 510(k) number is K242469.

When was RFMagik Lite approved by the FDA?

RFMagik Lite received FDA 510(k) clearance on 2025-04-25, under approval number K242469.

What company makes RFMagik Lite?

RFMagik Lite is manufactured by Agnes Medical Co., Ltd..

What is the FDA product code for RFMagik Lite?

The FDA product code for RFMagik Lite is GEI.

Other Devices by Agnes Medical Co., Ltd.

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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.