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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K213484
Device Name SmoothCool HR System
Applicant
Jeisys Medical Inc
307, 308, 401, Daeryung Techno Town 8th, 96,
Gamasan-ro, Geumcheon-Gu
Seoul,  KR 08501
Applicant Contact Sang Hoon Hwang
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave. STE 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/29/2021
Decision Date 04/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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