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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Skin Resurfacing Rf Applicator
510(k) Number K142833
Device Name INTRAGen
Applicant
Jeisys Medical, Inc.
307 Daerung Techno Tower 8th, 481-11
Gasan-Dong, Geumchen-Gu
Seoul,  KR 153-775
Applicant Contact Kyung Won Hwang
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
OUH  
Subsequent Product Code
GEI  
Date Received09/30/2014
Decision Date 06/04/2015
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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