21 C.F.R. § 886.1930

Tonometer and accessories.

Last amended: 2016Year: 2026Length: 79 wordsSubsections: 2Official source

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.
21 C.F.R. § 886.1930: Tonometer and accessories. | Justis AI