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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K251825
Device Name Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz.
# 8 Keyuan Rd., Science Park Community, Yuehai Sub-District
Shenzhen,  CN
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
Shenzhen,  CN
Correspondent Contact Blue Yang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received06/13/2025
Decision Date 10/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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