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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 K223862
Device Name Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Applicant
Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu
64, Techno 8-Ro, Yuseong-Gu,  KR 34028
Applicant Contact Hyun Sik Yoon
Correspondent
Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu
64, Techno 8-Ro, Yuseong-Gu,  KR 34028
Correspondent Contact Hyun Sik Yoon
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/23/2022
Decision Date 04/28/2023
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
Predetermined Change
Control Plan Authorized		 No
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