21 C.F.R. § 886.1670
Ophthalmic isotope uptake probe.
Cite as 21 C.F.R. § 886.1670 (2026)
(a)
Identification.
An ophthalmic isotope uptake probe is an AC-powered device intended to measure, by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.
(b)
Classification.
Class II.