AROMA GRAND

Powered Laser Surgical Instrument

Daeju Meditech Engineering Co., Ltd.

The following data is part of a premarket notification filed by Daeju Meditech Engineering Co., Ltd. with the FDA for Aroma Grand.

Pre-market Notification Details

Device IDK211637
510k NumberK211637
Device Name:AROMA GRAND
ClassificationPowered Laser Surgical Instrument
Applicant Daeju Meditech Engineering Co., Ltd. #501-504, HausD Sejong Tower, 26, Seongsu-il-ro L0gil, Seongdong-gu Seoul,  KR 04793
ContactSeongun Kim
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-27
Decision Date2021-09-03

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