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510(k) Data Aggregation

    K Number
    K072904
    Device Name
    SONOCA 180/195 WOUND CARE SYSTEM
    Manufacturer
    SOERING GMBH
    Date Cleared
    2008-05-21

    (223 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOERING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SONOCA 180/185 Wound Care System is an instrument intended for selected ultrasound dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for removal of debris, exudates, fragments, and other matter.
    Device Description
    Ultrasonic-Assisted Wound Treatment using the Sonoca 180 / 185 applies low-frequency power ultrasound in conjunction with an irrigation solution via a moving receptacle directly to the wound tissue. An ultrasonic generator transfers electric energy to a receptacle where a high-precision piezoelectric crystal system (PZT transducer) transforms this energy into mechanic vibrations: 25,000 vibrations / second (= 25 kHz). The receptacle is continuously moved over the wound surface. This allows gentle loosening of necrotic tissue and fibrin layers and flushes them away with the irrigation solution (0.9 % NaCl or Ringer solution). The liquid is used for transmitting the ultrasound as well as for wound irrigation. Cavitation is the underlying mode of action of ultrasound: the formation and disintegration of cavities (bubbles) in liquids due to pressure fluctuations, i.e. formation and subsequent implosion of these bubbles causes turbulences and currents on the wound surface, which help to loosen necrotic tissue and fibrin layers.
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