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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 Hair Removal
510(k) Number K251984
Device Name Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Tech Plaza, # 8
Keyuan Rd., Science Pk Cmty Yuehai Sub-Dist. Nanshan Dist
Shenzhen,  CN 518000
Applicant Contact Yang Blue
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Tech Plaza, # 8
Keyuan Rd., Science Pk Cmty Yuehai Sub-Dist. Nanshan Dist
Shenzhen,  CN 518000
Correspondent Contact Yang Blue
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/27/2025
Decision Date 07/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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