FDA Product Code SCW: Digital Prismatic Correction
The Device Is Intended To Provide Digital Image Adjustments In A Display System In Accordance With A Users Prism Prescription. The Device Can Be Used In Conjunction With Optical Lenses For Refractive Correction.
Leading manufacturers include Apple, Inc..
2
Total
2
Cleared
128d
Avg days
2024
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Digital Prismatic Correction Devices (Product Code SCW)
2 devices
Cleared
Jun 23, 2025
Digital Prism Correction Feature (DPCF)
Apple, Inc.
Ophthalmic
157d
Cleared
Oct 21, 2024
Digital Prism Correction Feature (DPCF)
Apple, Inc.
Ophthalmic
98d
About Product Code SCW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SCW since 2024, with 2 receiving FDA clearance (average review time: 128 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.