21 CFR 886.4280 — Intraocular, Pressure Measuring Device

Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4280

Identification

An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.

Classification Rationale

Class III.

Product Codes

Product CodeDevice NameClassDevicesAttributes
NVBIntraocular, Pressure Measuring Device30
Innolitics

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