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510(k) K260895

Ulike Clear Zero (YC10 BU) by Guangxi Ulike Medical Technology Co., Ltd. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
March 18, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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