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..
FDA 510(k) Cleared Digital Prismatic Correction Devices (Product Code SCW)
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.
SCW devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →