21 CFR § 886.1670
Ophthalmic isotope uptake probe
June 25, 2020
(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.