FDA 510(k) Application Details - K202670

Device Classification Name	Endoilluminator   More FDA Info for this Device
510(K) Number	K202670
Device Name	Endoilluminator
Applicant	Oculight Ltd. Seongnamdaelo 1342, B111 Seongnam-si 13120 KR Other 510(k) Applications for this Company
Contact	Jinman Kim Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	MPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2020
Decision Date	08/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review