21 CFR 886.1090 — Brush, Haidinger, (Including Macular Integrity)

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1090

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HIYBrush, Haidinger, (Including Macular Integrity)10
Innolitics

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