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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 K260742
Device Name Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
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 Xue Dai
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 Xue Dai
Regulation Number878.4810
Classification Product Code
OHT  
Date Received03/06/2026
Decision Date 05/05/2026
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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