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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 K240649
Device Name Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz.,
# 8 Keyuan Rd., Science Park Community, Yuehai Sub-Distri
Shenzhen,  CN 518000
Applicant Contact Blue Yang
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz.,
# 8 Keyuan Rd., Science Park Community, Yuehai Sub-Distri
Shenzhen,  CN 518000
Correspondent Contact Blue Yang
Regulation Number878.4810
Classification Product Code
OHT  
Date Received03/07/2024
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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