SCW — Digital Prismatic Correction Class I
FDA product code SCW covers "Digital Prismatic Correction", a Class I medical device regulated under 21 CFR 886.1655. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SCW
- Device Class
- Class I
- Regulation Number
- 886.1655
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.