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Digital Prismatic Correction

FDA product code SCW · 2 cleared devices

Class 1 Ophthalmic
Regulation
21 CFR 886.1655
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-10-21 – 2025-06-23

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.

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