← FDA Medical Device Classifications

Digital Prismatic Correction

SCW · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1655

Classification

FDA Product Code
SCW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.1655
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
2
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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