Device typeGeneral cryosurgical system, cryogen gas, electronic: An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.
FDA categoryDevice, Surgical, Cryogenic
Device ID00816287020248
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information