DeviceClearance

Product code SCW— Ophthalmic

Digital Prism Correction Feature (DPCF)

Classification name
Digital Prismatic Correction
Device class
Class 1
Regulation
21 CFR 886.1655
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SCW under 21 CFR 886.1655, via openFDA

Market context for product code SCW

FDA has cleared 2 devices under product code SCW between 2024 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code SCW

Recent clearances under product code SCW

Data sourced from openFDA. This site is unofficial and independent of the FDA.