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FDA 510(k)

Youmagic FLM System (YM5-U1)

K-Number: K240857 · 2025-05-15

ApplicantWe Medical Technology (Wuxi) Co., Ltd.
Decision Date2025-05-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Youmagic FLM System (YM5-U1) is a medical device manufactured by We Medical Technology (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2025-05-15 under approval number K240857. 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 Youmagic FLM System (YM5-U1)?

Youmagic FLM System (YM5-U1) is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by We Medical Technology (Wuxi) Co., Ltd.. The 510(k) number is K240857.

When was Youmagic FLM System (YM5-U1) approved by the FDA?

Youmagic FLM System (YM5-U1) received FDA 510(k) clearance on 2025-05-15, under approval number K240857.

What company makes Youmagic FLM System (YM5-U1)?

Youmagic FLM System (YM5-U1) is manufactured by We Medical Technology (Wuxi) Co., Ltd..

What is the FDA product code for Youmagic FLM System (YM5-U1)?

The FDA product code for Youmagic FLM System (YM5-U1) is GEI.

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Official Source

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