Device typeOphthalmic cryosurgical system, mechanical: An assembly of mechanical devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes a mechanical regulator to control the flow of cryogen contained in an attached cylinder, and dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue. The device is typically used to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumours.
FDA categoryUnit, Cryophthalmic
Device ID88719214223454
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information