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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, comb, hair
510(k) Number K192425
Device Name Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
Applicant
Won Tech Co., Ltd.
64 Techno 8-Ro, Yuseong-gu
Daejeon,  KR 34028
Applicant Contact Jake Yu
Correspondent
Won Tech Co., Ltd.
64 Techno 8-Ro, Yuseong-gu
Daejeon,  KR 34028
Correspondent Contact Jake Yu
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/05/2019
Decision Date 09/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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