FDA 510(k) Application Details - K221375

Device Classification Name	More FDA Info for this Device
510(K) Number	K221375
Device Name	CureSight-CS100
Applicant	NovaSight Ltd. 1 Hayarden St. Airport City 7019801 IL Other 510(k) Applications for this Company
Contact	Ran Yam Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2022
Decision Date	09/29/2022
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