Cleared Traditional

K242058 - Digital Prism Correction Feature (DPCF)

K242058 is an FDA 510(k) clearance for Digital Prism Correction Feature (DPCF), manufactured by Apple, Inc.. The device is a Class 1 Ophthalmic device with product code SCW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K242058 · Apple, Inc. · Ophthalmic device
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Oct 2024
Decision
98d
Days
Class 1
Risk

K242058 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 October 21, 2024 after a review of 98 days - within the typical 510(k) review window.

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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FDA 510(k) Submission Details - K242058

510(k) Number K242058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2024
Decision Date October 21, 2024
Days to Decision 98 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
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

SCW Device Classification - Class 1, General Controls

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.