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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K153727
Device Name INTRAcel Premium Fractional RF Micro Needle (FRM) System
Applicant
Jeisys Medical, Inc.
307,Daeryung Techno Town 8th, Gamasan-Ro 96,
Geumcheon-Gu
Seoul,  KR 153-775
Applicant Contact HYOSEOK LEE
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/28/2015
Decision Date 07/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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