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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 K172968
Device Name Hair Up
Applicant
Y & J Bio Co., Ltd.
# C-413, Munjeong Hyundai Knowledge Center 1, 7
Beobwon-Ro 11-Gil
Seoul,  KR 05836
Applicant Contact Kwang Sic Kim
Correspondent
Bt Solutions, Inc.
Unit 502, 148 Yeoksam-Ro
Seoul,  KR 06249
Correspondent Contact Mina Joo
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/26/2017
Decision Date 01/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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