Medical Device Manufacturer · US , Alexandria , VA

Apple, Inc. - FDA 510(k) Cleared Devices

12 submissions · 9 cleared · Since 2018

Official Website

12

Total

9

Cleared

3

Denied

FDA 510(k) Regulatory Record - Apple, Inc. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Jun 23, 2025

Digital Prism Correction Feature (DPCF)

Ophthalmic · 157d

Cleared Oct 21, 2024

Digital Prism Correction Feature (DPCF)

Ophthalmic · 98d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026