21 C.F.R. § 886.1385
Polymethylmethacrylate (PMMA) diagnostic contact lens.
Cite as 21 C.F.R. § 886.1385 (2026)
(a)
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.
(b)
Classification.
Class II.