Cleared Traditional

Digital Prism Correction Feature (DPCF)

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

About This 510(k) Submission

K242058 is an FDA 510(k) clearance for the Digital Prism Correction Feature (DPCF), a Digital Prismatic Correction (Class I — General Controls, product code SCW), submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on October 21, 2024, 98 days after receiving the submission on July 15, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1655.

Submission Details

510(k) Number K242058 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code SCW — Digital Prismatic Correction
Device Class Class I — 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.