21 CFR 886.1450 — Instrument, Measuring, Corneal Radius

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1450

Identification

A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.

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, only when the device does not include computer software in the unit or topographers.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HJBInstrument, Measuring, Corneal Radius15
Innolitics

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