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510(k) K242058

Digital Prism Correction Feature (DPCF) by Apple, Inc. — Product Code SCW

K242058 is an FDA 510(k) premarket notification submitted by Apple, Inc. for the device "Digital Prism Correction Feature (DPCF)". The FDA issued a decision of Substantially Equivalent on October 21, 2024. The device falls under product code SCW (Digital Prismatic Correction), a Class I device regulated under 21 CFR 886.1655. Apple, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2024
Date Received
July 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digital Prismatic Correction
Device Class
Class I
Regulation Number
886.1655
Review Panel
OP
Submission Type

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 clearances by Apple, Inc.

  • K253582 — Medical Imaging Calibration Feature (MICF) (April 1, 2026)
  • K250507 — Hypertension Notification Feature (HTNF) (September 11, 2025)
  • K250143 — Digital Prism Correction Feature (DPCF) (June 23, 2025)
  • K240929 — Sleep Apnea Notification Feature (SANF) (September 13, 2024)
  • DEN230081 — Hearing Aid Feature (HAF) (September 12, 2024)
  • K231173 — Irregular Rhythm Notification Feature (IRNF) (July 21, 2023)
  • K213971 — Atrial Fibrillation History Feature (June 3, 2022)
  • K212516 — IRNF App (October 22, 2021)
  • K201525 — ECG App (October 8, 2020)
  • DEN180044 — ECG App (September 11, 2018)

Other clearances for product code SCW

  • K250143 — Digital Prism Correction Feature (DPCF) (June 23, 2025)

FDA data resources