21 C.F.R. § 886.1930
Tonometer and accessories.
Cite as 21 C.F.R. § 886.1930 (2026)
(a)
Identification.
A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
(b)
Classification.
Class II.