Digital Prism Correction Feature (DPCF)
FDA 510(k) clearance K250143 · decided 2025-06-23
Clearance details
- K-number
- K250143
- Device name
- Digital Prism Correction Feature (DPCF)
- Applicant
- Apple, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-17
- Decision date
- 2025-06-23
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- SCW
- Device class
- 1
- Regulation number
- 886.1655
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Digital Prism Correction Feature (DPCF) (K242058) | Apple, Inc. | 2024-10-21 |
Recalls involving this device
No recalls on record reference this clearance.