Digital Prismatic Correction
A digital prismatic correction device provides digital image adjustments in a display system in accordance with a user's prism prescription, compensating for binocular vision disorders; it can be used in conjunction with optical lenses for refractive correction. It is classified as FDA Class I (general controls) under regulation 886.1655 in the Ophthalmic specialty, with product code SCW, and does not require premarket notification. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SCW
- Device Class
- FDA class 1
- Regulation Number
- 886.1655
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.