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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 K180617
Device Name Hair Up
Y&J BIO Co, Ltd.,
No. C-413, Munjeong Hyundai Knowledge Center 1,
7, Beobwon-gil
Seoul,  KR 05836
Applicant Contact Kwang Sic Kim
BT Solutions, Inc.
91-14 Seolleung-ri #402
Gangnam-gu,  KR 06150
Correspondent Contact Mina Joo
Regulation Number890.5500
Classification Product Code
Date Received03/08/2018
Decision Date 06/01/2018
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