Digital Prismatic Correction

FDA product code SCW · Class I (low risk) · 21 CFR 886.1655 · 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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K250143Digital Prism Correction Feature (DPCF)SCW · Traditional Apple, Inc.06/23/2025SE
K242058Digital Prism Correction Feature (DPCF)SCW · Traditional Apple, Inc.10/21/2024SE