FDA 510(k) Application Details - K183471

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K183471
Device Name	Laser,Fluorescence Caries Detection
Applicant	Good Doctors Co.,Ltd. #208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu Incheon 21315 KR Other 510(k) Applications for this Company
Contact	Sungro Joo Other 510(k) Applications for this Contact
Regulation Number	872.1745   More FDA Info for this Regulation Number
Classification Product Code	NBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2018
Decision Date	07/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review