21 C.F.R. § 882.5500

Lesion temperature monitor.

Last amended: 2016Year: 2026Length: 44 wordsSubsections: 2Official source

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).
21 C.F.R. § 882.5500: Lesion temperature monitor. | Justis AI