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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K260895
Device Name Ulike Clear Zero (YC10 BU)
Applicant
Guangxi Ulike Medical Technology Co., Ltd.
Rm. 605, Bldg. 1, Northwest Of Intersection Of Renhou Rd. An
Yulin,  CN
Applicant Contact Blue Yang
Correspondent
Guangxi Ulike Medical Technology Co., Ltd.
Rm. 605, Bldg. 1, Northwest Of Intersection Of Renhou Rd. An
Yulin,  CN
Correspondent Contact Blue Yang
Regulation Number882.5890
Classification Product Code
NFO  
Date Received03/18/2026
Decision Date 05/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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