SCW — Digital Prismatic Correction Class I

FDA Device Classification

Classification Details

Product Code
SCW
Device Class
Class I
Regulation Number
886.1655
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250143appleDigital Prism Correction Feature (DPCF)June 23, 2025
K242058appleDigital Prism Correction Feature (DPCF)October 21, 2024