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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 K250938
Device Name Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810,Bldg. 1,Xunmei Science And Tech Plaza, #8 Keyuan Rd.
Science Park Community, Yuehai Sub-District, Nanshan Dist
Shenzhen,  CN
Applicant Contact Blue Yang
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810,Bldg. 1,Xunmei Science And Tech Plaza, #8 Keyuan Rd.
Science Park Community, Yuehai Sub-District, Nanshan Dist
Shenzhen,  CN
Correspondent Contact Blue Yang
Regulation Number878.4810
Classification Product Code
OHT  
Date Received03/28/2025
Decision Date 05/23/2025
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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