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 CodeDevice NameClassDevicesAttributes
HJDIlluminator, Color Vision Plate11
NFDSelector, Color, Spectacle, Lens, Tint11
Innolitics

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