510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SCWClass I

Digital Prismatic Correction

21 CFR 886.1655 / Ophthalmic
FDA source (opens on fda.gov)

SCW is the FDA product code for Digital Prismatic Correction, a class I device type, regulated under 21 CFR 886.1655. FDA's definition for this code reads: "The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SCW
Device name
Digital Prismatic Correction
FDA definition
The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction.
Regulation
21 CFR 886.1655
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SCW

By decision year
2 clearances under product code SCW with a decision year between 2024 and 2025, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SCW by decision year
YearClearances
20241
20251

Applicants with the most clearances

Product code SCW
Applicants holding the most 510(k) clearances under product code SCW
ApplicantClearances
Apple Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code