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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 K243393
Device Name JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz., # 8
Keyuan Rd., Science Park Community, Yuehai Sub-District, Na
Shenzhen,  CN 518000
Applicant Contact Blue Yang
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz., # 8
Keyuan Rd., Science Park Community, Yuehai Sub-District, Na
Shenzhen,  CN 518000
Correspondent Contact Blue Yang
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
OHS  
Date Received10/31/2024
Decision Date 02/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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