IC-WHCD100 (Inspire)

Laser, Fluorescence Caries Detection

Good Doctors Co.,Ltd.

The following data is part of a premarket notification filed by Good Doctors Co.,ltd. with the FDA for Ic-whcd100 (inspire).

Pre-market Notification Details

Device IDK183471
510k NumberK183471
Device Name:IC-WHCD100 (Inspire)
ClassificationLaser, Fluorescence Caries Detection
Applicant Good Doctors Co.,Ltd. #208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu Incheon,  KR 21315
ContactSungro Joo
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine,  CA  92620
Product CodeNBL  
CFR Regulation Number872.1745 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-14
Decision Date2020-07-02

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