eCFR.io
Daily eCFR

§ 882.5500 Lesion temperature monitor.

21 CFR 882.5500

Citation21 CFR 882.5500
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 882.5500 Lesion temperature monitor.

(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).