# K250143: Digital Prism Correction Feature (DPCF)

- Pathway: 510(k) (Traditional)
- Applicant: Apple, Inc.
- Decided: Jun 23, 2025 after 157 days
- Product code: SCW (Digital Prismatic Correction)
- Device class: 1
- Regulation: 21 CFR 886.1655
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K240585: Digital Prism Correction Feature (DPCF). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Indications for use
The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription. DPCF is available over-the-counter (OTC) for users with prism in their eyeglass prescription. When a prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro. DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimension (i.e., base-up, base-down, base-in, base-out), per eye.

Source page: https://510kreport.com/device/K250143
Methodology: https://510kreport.com/methodology