FDA 510(k) Application Details - K250143

Device Classification Name	More FDA Info for this Device
510(K) Number	K250143
Device Name	Digital Prism Correction Feature (DPCF)
Applicant	Apple Inc. One Apple Park Way Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Ian Marcus Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2025
Decision Date	06/23/2025
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