Cleared Traditional

K250143 - Digital Prism Correction Feature (DPCF) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K250143 · Apple, Inc. · Ophthalmic device
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Jun 2025
Decision
157d
Days
Class 1
Risk

K250143 is an FDA 510(k) clearance for the Digital Prism Correction Feature (DPCF). Classified as Digital Prismatic Correction (product code SCW), Class I - General Controls.

Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 23, 2025 after a review of 157 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1655 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K250143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date June 23, 2025
Days to Decision 157 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 110d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SCW Digital Prismatic Correction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1655
Definition The Device Is Intended To Provide Digital Image Adjustments In A Display System In Accordance With A User’s Prism Prescription. The Device Can Be Used In Conjunction With Optical Lenses For Refractive Correction.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.