510(k) K242058
- Device
- Digital Prism Correction Feature (DPCF)
- Applicant
- Apple, Inc.
- 510(k) number
- K242058
- Product code
- SCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-21
- Date received
- 2024-07-15
- Regulation
- 886.1655
- Classification name
- Digital Prismatic Correction
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ian Marcus
- Address
- One Apple Park Way Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3014343954
Source Documents#
Other 510(k) Records For Product Code SCW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250143 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | 2025-06-23 |