SCW

Digital Prismatic Correction

Product code

SCW

Device name

Digital Prismatic Correction

Device class

Class 1

21 CFR

21 CFR 886.1655

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-06-23.

2 summaries are archived here for direct download.