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FDA PRODUCT CODE · CLASS I

SCW — Digital Prismatic Correction

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.

DEVICE CLASS
Class I
REGULATION
21 CFR 886.1655
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K250143Apple, Inc. · 510k2025-06-23
K242058Apple, Inc. · 510k2024-10-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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