FDA 510(k) Application Details - K243878

Device Classification Name	More FDA Info for this Device
510(K) Number	K243878
Device Name	CLARUS (700)
Applicant	Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, CA 94568 US Other 510(k) Applications for this Company
Contact	Tanesha Bland Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2024
Decision Date	04/17/2025
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