FDA product code SCW: Digital Prismatic Correction
SCW is the FDA product code for digital prismatic correction. It is a Class I device, regulated under 21 CFR 886.1655 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under SCW, 2 in the last five years. The average 510(k) review took 128 days (median 128); 128 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Digital Prismatic Correction |
| Device class | Class I |
| Regulation | 21 CFR 886.1655 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SCW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 98 |
| 2025 | 1 | 157 |
Compare with all 510(k) review times · Search every SCW clearance
Top SCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apple, Inc. | 2 | 2025-06-23 |
Most recent SCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250143 | Apple, Inc. | Digital Prism Correction Feature (DPCF) | 2025-06-23 | 157 |
| K242058 | Apple, Inc. | Digital Prism Correction Feature (DPCF) | 2024-10-21 | 98 |
Recalls for SCW devices
openFDA lists no recalls for product code SCW.
Frequently asked questions
What is FDA product code SCW?
SCW is the FDA product code for digital prismatic correction. It is a Class I device, regulated under 21 CFR 886.1655 and reviewed by the Ophthalmic panel.
What device class is SCW?
Class I, regulation 21 CFR 886.1655. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SCW?
Across 2 cleared submissions the average was 128 days from receipt to decision (median 128).
Which companies have the most SCW clearances?
Apple, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code SCW
- Run a recall and safety report across every SCW manufacturer
- Watch product code SCW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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