K242058 is an FDA 510(k) clearance for the Digital Prism Correction Feature (DPCF). This device is classified as a Digital Prismatic Correction (Class I - General Controls, product code SCW).
Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on October 21, 2024, 98 days after receiving the submission on July 15, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1655. 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) Number | K242058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2024 |
| Decision Date | October 21, 2024 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | SCW - Digital Prismatic Correction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1655 |
| 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. |