StacksVerified U.S. regulatory reference

21 CFR §882.4400

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.
  2. (b)Classification. Class II (performance standards).