Product code SCW

Device name

Digital Prismatic Correction

Medical specialty

Ophthalmic

Device class

1

Regulation number

886.1655

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset