FDA 510(k) Application Details - K222933

Device Classification Name	Device,Analysis,Anterior Segment   More FDA Info for this Device
510(K) Number	K222933
Device Name	Device,Analysis,Anterior Segment
Applicant	VISIA Imaging S.r.l. Via Martiri della Libertα 95/e San Giovanni Valdarno 52027 IT Other 510(k) Applications for this Company
Contact	Alessia Magnanini Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	MXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2022
Decision Date	06/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review