NFD · Selector, Color, Spectacle, Lens, Tint
Ophthalmic · 21 CFR 886.1160 · Class 1
Overview
| Product Code | NFD |
|---|---|
| Device Name | Selector, Color, Spectacle, Lens, Tint |
| Regulation | 21 CFR 886.1160 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K012298 | THE INTUITIVE COLORIMETER | Cerium Optical Technologies, Inc. | Sep 26, 2001 | SESE |
Top Applicants
- Cerium Optical Technologies, Inc. — 1 clearance
