Digital Prism Correction Feature (DPCF)

FDA 510(k) K242058 · Apple, Inc.

Substantially Equivalent

510(k) numberK242058

Submission

Device name
Digital Prism Correction Feature (DPCF)
Applicant
Apple, Inc.
Cupertino, CA, US
Received
July 15, 2024
Decision date
October 21, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SCW – Digital Prismatic Correction
Device class
Class I (low risk)
Regulation
21 CFR 886.1655
Specialty
Ophthalmic

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.

Other 510(k)s with product code SCW

510(k)DeviceApplicantDecision
K250143Digital Prism Correction Feature (DPCF)SCW · Traditional Apple, Inc.06/23/2025SE

More from Apple, Inc.

510(k)DeviceDecision
K253582Medical Imaging Calibration Feature (MICF)SHN · Traditional 04/01/2026SE
K250507Hypertension Notification Feature (HTNF)SFR · Traditional 09/11/2025SE
K250143Digital Prism Correction Feature (DPCF)SCW · Traditional 06/23/2025SE
K240929Sleep Apnea Notification Feature (SANF)QZW · Traditional 09/13/2024SE
K231173Irregular Rhythm Notification Feature (IRNF)QDB · Traditional 07/21/2023SE
K213971Atrial Fibrillation History FeatureQDB · Traditional 06/03/2022SE
K212516IRNF AppQDB · Traditional 10/22/2021SE
K201525ECG AppQDA · Traditional 10/08/2020SE

Questions and answers

When was Digital Prism Correction Feature (DPCF) cleared by the FDA?

Digital Prism Correction Feature (DPCF) (K242058) received a 510(k) decision of Substantially Equivalent on October 21, 2024, 98 days after the submission was received.

What is the product code of K242058?

The FDA product code is SCW – Digital Prismatic Correction, a Class I (low risk) device regulated under 21 CFR 886.1655.