FDA 510(k) Application Details - K221111

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K221111
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Topcon Corporation 75-1 Hasunuma-Cho Itabashi-Ku 174-8580 JP Other 510(k) Applications for this Company
Contact	Ryota Kitawaki Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2022
Decision Date	08/29/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review