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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 K241205
Device Name Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1,Xunmei Science And Technology Plz.,# 8 Keyuan
Rd., Science Park Community,Yuehai Sub-District, Nanshan Dis
Shenzhen,  CN
Applicant Contact Yang Blue
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1,Xunmei Science And Technology Plz.,# 8 Keyuan
Rd., Science Park Community,Yuehai Sub-District, Nanshan Dis
Shenzhen,  CN
Correspondent Contact Yang Blue
Regulation Number878.4810
Classification Product Code
OHT  
Date Received04/30/2024
Decision Date 09/09/2024
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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