Cleared Traditional

K242058 - Digital Prism Correction Feature (DPCF) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K242058 · Apple, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Apple, Inc. devices

Submission Details

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.

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.