Digital Prism Correction Feature (DPCF)— 510(k) K250143

Name: FDA 510(k) clearance K250143
Creator: U.S. Food and Drug Administration
Published: 2025-06-23

Substantially Equivalent

Apple, Inc.

FDA 510(k) clearance K250143 for Digital Prism Correction Feature (DPCF), Substantially Equivalent on 2025-06-23. Applicant: Apple, Inc.. Device class: 1.

Clearance details

Applicant: Apple, Inc.
Product code: Code SCW
Device class: Class 1
Regulation: 21 CFR 886.1655
Advisory panel: Ophthalmic
Date received: 2025-01-17
Decision date: 2025-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SCW

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K242058 — Digital Prism Correction Feature (DPCF)2024-10-21

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