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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 K182562
Device Name Hair Boom 69
64 Techno 8-ro, Yuseong-gu
Daejeon,  KR 305-500
Applicant Contact Gyuri (Erin) Park
NST Consultants, Inc.
642 Shunpike Road, Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
Date Received09/18/2018
Decision Date 11/16/2018
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