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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name focused ultrasound for tissue heat or mechanical cellular disruption
510(k) Number K181896
Device Name LIPOcel
Applicant
Jeisys Medical, Inc.
307, Daeryung Techno Town 8th,
Gamasan-ro 96, Geumcheon-Gu
seoul,  KR 153-775
Applicant Contact sugun lee
Correspondent
Elexes Medical Consulting
6494 Tralee Village Dr
dr dublin,  CA  94568
Correspondent Contact parul chansoria
Regulation Number878.4590
Classification Product Code
OHV  
Date Received07/16/2018
Decision Date 10/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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