FDA 510(k) Application Details - K222372

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K222372
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu-shi 1820021 JP Other 510(k) Applications for this Company
Contact	Nariaki Morita Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	HJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2022
Decision Date	11/21/2022
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