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FDA 510(k)

RFMagik Lite

K-Number: K242469 · 2025-04-25

ApplicantAgnes Medical Co., Ltd.
Decision Date2025-04-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RFMagik Lite is the device name listed in this FDA 510(k) record. The listed applicant is Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) 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. The listed applicant is Agnes Medical Co., Ltd.. The 510(k) number is K242469.

When did RFMagik Lite receive FDA 510(k) clearance?

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

Who is the listed applicant for RFMagik Lite?

The FDA 510(k) record lists Agnes Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RFMagik Lite?

The FDA product code for RFMagik Lite is GEI.

Other records listing Agnes Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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