21 C.F.R. § 882.5500
Lesion temperature monitor.
Cite as 21 C.F.R. § 882.5500 (2026)
(a)
Identification.
A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe.
(b)
Classification.
Class II (performance standards).