21 CFR § 882.5500 - Lesion temperature monitor.

---
identifier: "/us/cfr/t21/s882.5500"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.5500 - Lesion temperature monitor."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.5500"
section_name: "Lesion temperature monitor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 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).