Last synced on 14 November 2025 at 11:06 pm

Youmagic FLM System (YM5-U1)

Page Type
Cleared 510(K)
510(k) Number
K240857
510(k) Type
Traditional
Applicant
WE Medical Technology (Wuxi) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/15/2025
Days to Decision
413 days
Submission Type
Summary

Youmagic FLM System (YM5-U1)

Page Type
Cleared 510(K)
510(k) Number
K240857
510(k) Type
Traditional
Applicant
WE Medical Technology (Wuxi) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/15/2025
Days to Decision
413 days
Submission Type
Summary