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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 K211637
Device Name AROMA GRAND
Applicant
Daeju Meditech Engineering Co., Ltd.
#501-504, Hausd Sejong Tower, 26,
Seongsu-Il-Ro L0gil, Seongdong-Gu
Seoul,  KR 04793
Applicant Contact Seongun Kim
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/27/2021
Decision Date 09/03/2021
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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