HIY · Brush, Haidinger, (Including Macular Integrity)
Ophthalmic · 21 CFR 886.1090 · Class 1
Overview
| Product Code | HIY |
|---|---|
| Device Name | Brush, Haidinger, (Including Macular Integrity) |
| Regulation | 21 CFR 886.1090 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
