21 CFR 886.1160 — Illuminator, Color Vision Plate
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1160
Identification
A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plates. It may include a filter.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HJD | Illuminator, Color Vision Plate | 1 | 1 | |
| NFD | Selector, Color, Spectacle, Lens, Tint | 1 | 1 |