Search Results
Found 1 results
510(k) Data Aggregation
K Number
K172049Device Name
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
Manufacturer
Date Cleared
2017-08-30
(55 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
Cry IQ AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CryoIQ Multi LINE are reusable devices intended to destroy tissue during surgical procedures by applying extreme cold.
Device Description
The CryoIQ devices consist of a unit body with a lever and an applicator (capillary tube, tip). A disposable cartridge filled with nitrous oxide (N₂O, laughing qas) will be attached to the unit body by slightly screwing into it. The cartridge has a build-in valve for safety storage and release of the gas. The CryoIQ designed to dispense a continuous stream of liquid nitrous oxide when actuated by pressing the lever. The device functions by means of heat evaporation upon phase transition where the nitrous oxide is applied to the treatment area by means of the applicator (capillary tube, tip) at a constant temperature of -89°C/-128°F (cold performance) followed by evaporation. Physicians or medical professionals can use the gas in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C/-128°F).
Ask a Question
Ask a specific question about this device
Page 1 of 1