21 CFR 886.1385 — Lens, Contact, Polymethylmethacrylate, Diagnostic

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1385

Identification

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HJKLens, Contact, Polymethylmethacrylate, Diagnostic2413rd Party
NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)21
Innolitics

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