510(k) K250143
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2025
- Date Received
- January 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Prismatic Correction
- Device Class
- Class I
- Regulation Number
- 886.1655
- Review Panel
- OP
- Submission Type
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.