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510(k) Data Aggregation
K Number
K170810Device Name
CRYOFOS
Manufacturer
CRYOFOS Medical Gmbh
Date Cleared
2017-09-27
(194 days)
Product Code
GEH, MLY
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYOFOS Medical Gmbh
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRYOFOS and Accessories indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
Device Description
The CRYOFOS and Accessories is a topical refrigerant that acts as a vapocoolant. The CRYOFOS system consists of a pistol grip handpiece, console for controlling operations, a rechargeable battery (Panasonic R127R2PG), and a cvlinder of compressed medical grade Carbon Dioxide (CO2) gas (sold separately). The CRYOFOS has a user interface that displays treatment activation. The CRYOFOS system delivers a topical spray of compressed medical grade (CO2) that is pure, dry bacteriostatic and non-explosive via the pistol grip handpiece. The device uses the natural expansion of liquid CO2 in the atmosphere to create a cold spray of microcrystals delivered under pressure. The expansion cooling of the treatment gas forms a micro-crystalline dry-ice mist with which the cooling effect required for treatment is achieved. The end-user uses a gradual circular or panning motion with the handpiece to apply the CO2 to the treatment site for 30-60 seconds at a distance of approximately 7cm. Rapid cooling (thermal shock) of the skin occurs at temperatures of 2-4°C in 30 sec when the spray sublimates (pass directly from solid / ice phase to gas phase) as it contacts the skin.
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