StacksVerified U.S. regulatory reference

21 CFR §882.5500

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II (performance standards).