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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 K261325
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 Technology Plz., # 8 Keyuan
Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guan
Shenzhen,  CN
Applicant Contact Blue Yang
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz., # 8 Keyuan
Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guan
Shenzhen,  CN
Correspondent Contact Blue Yang
Regulation Number878.4810
Classification Product Code
OHT  
Date Received04/22/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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