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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Prismatic Correction
510(k) Number K242058
Device Name Digital Prism Correction Feature (DPCF)
Applicant
Apple, Inc.
One Apple Park Way
Cupertino,  CA  95014
Applicant Contact Ian Marcus
Correspondent
Apple, Inc.
One Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Ian Marcus
Regulation Number886.1655
Classification Product Code
SCW  
Date Received07/15/2024
Decision Date 10/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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