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510(k) Data Aggregation

    K Number
    K162721
    Device Name
    Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
    Manufacturer
    ALLIQUA BIOMEDICAL, INC.
    Date Cleared
    2016-12-22

    (84 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIST Systems produce a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.
    Device Description
    MIST Systems (e.g., UltraMIST System) are low frequency ultrasound devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to the treatment site. The atomized fluid allows the treatment to be performed without direct contact to the patient. MIST Systems are made up of a main generator component, treatment wand, and disposable applicator. MIST Systems deliver low-frequency ultrasound to the treatment site using an atomized fluid mist. The mist is generated from a small, portable system consisting of a generator, a treatment wand (encasing an ultrasound transducer), and a disposable applicator that has been designed to connect to a user-provided fluid source (e.g., IV saline bag). The system provides a flow of fluid (irrigant) to the tissue surface by the use of low frequency, low intensity ultrasound. Only the mist touches the tissue, not the ultrasound radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow of fluid as an irrigant is controlled by a peristaltic pump on the generator unit. The fluid is dispensed onto the ultrasound radiation surface where the mist is generated. The mist is projected by fundamental atomization or nebulization and acoustic streaming or acoustic radiation force respectively.
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    K Number
    K140782
    Device Name
    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2014-08-13

    (135 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.
    Device Description
    Not Found
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    K Number
    K131096
    Device Name
    AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
    Manufacturer
    AROBELLA MEDICAL, LLC
    Date Cleared
    2014-05-16

    (393 days)

    Product Code
    NRB, LFL
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via: - Selective and non-selective dissection and fragmentation of soft and or hard tissue; - Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter. - Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue); - Contact and or non-contact maintenance debridement for the removal ofdebris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter. - Preparing the wound bed for graft or other subsequent procedures using contact and or non-contact techniques to achieve wound debridement.
    Device Description
    The AR1000 Ultrasonic Wound Therapy System and its variants use ultrasonic energy from a generator delivered by a conductive cable to a hand held converter through the converter's distal end probe and liquid coupling medium: to perform wound therapy; to perform ultrasonic surgical, excisional, and or sharp-edge selective dissection procedures; with the intended end result to promote healing. The AR1000 Ultrasonic Wound Therapy System generator utilizes commonly available wall outlet power (85 -260VAC, 50/60Hz) to produce the ultrasonic signal. A conductive cable connects the generator to the hand held converter. The hand held converter converts the signal into ultrasonic mechanical displacement in the distal end probe or Qurette. The ultrasonic mechanical displacement energy is applied to the treatment site by the distal end probe or Qurette through direct contact or noncontact techniques. The ultrasonic mechanical displacement energy is also transmitted as ultrasonic energy to the treatment site via the liquid coupling medium. The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is used with contact or non-contact modes to achieve intended wound therapy modalities to promote wound healing. This is achieved through the use of the low-frequency, controlled-intensity, ultrasonic energy to perform ultrasonic dissection and fragmentation of tissues, debridement of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue), and surgical, excisional or sharp-edge incisions. The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is used with contact or non-contact modes to achieve wound therapy and promotes wound healing through the ultrasonic dissection and fragmentation of tissues, debridement of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) through the use of the low-frequency, controlled-intensity, non-thermal ultrasonic energy. The AR1000 Ultrasonic Wound Therapy System ultrasonic energy, via the liquid coupling medium to the treatment site, promotes wound healing through the lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for the removal of debris, exudates, fragments, bacteria, and other matter. The AR1000 Ultrasonic Wound Therapy System uses continuous ultrasonic energy to propel the liquid medium (e.g. sterile saline, or other appropriate US FDA cleared medium) into a solution stream and couples the delivery of ultrasonic energy to the treatment site. This is accomplished by the ultrasonic energy application to the treatment site where the ultrasonic energy is transmitted via the converter probe (Qurette) and also coupled via the liquid medium to the treatment site. The converter has a transducer horn that is made from titanium alloy (TI-6AL-4V). The converter probe Qurette tips are made from titanium alloy (TI-6AL-4V). No latex is used in this device, including any potential patient-contact areas, and testing has revealed no negative reactions to the materials used in this device.
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    K Number
    K123980
    Device Name
    SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
    Manufacturer
    MISONIX, INC.
    Date Cleared
    2013-03-05

    (69 days)

    Product Code
    NRB, FQH
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers. bedsores and vaginal ulcers. soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
    Device Description
    The SonicOne Plus Ultrasonic Wound Care System and Accessories is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include Probe tips, Wrenches, Sterile and non sterile Tube sets and sterile Surgical Procedure bags and sterile Handpiece Sheaths.
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    K Number
    K122246
    Device Name
    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2012-08-13

    (17 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
    Device Description
    Not Found
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    K Number
    K112782
    Device Name
    MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
    Manufacturer
    MISONIX, INC.
    Date Cleared
    2011-12-01

    (66 days)

    Product Code
    NRB, FQH
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
    Device Description
    The SonicOne Ultrasonic Wound Care System is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include probe tips, wrenches, sterile and non sterile tube sets and sterile Surgical Procedure bags and handpiece sheaths.
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    K Number
    K091038
    Device Name
    AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
    Manufacturer
    AROBELLA MEDICAL, LLC
    Date Cleared
    2009-06-19

    (67 days)

    Product Code
    NRB, FQH
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter.
    Device Description
    The AS1000 Ultrasonic Wound Therapy System promotes wound healing through the ultrasonic lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation & maintenance debridement of the removal of debris, exudates, fragments, bacteria, and other matter through the use of low-frequency, low-intensity, nonthermal non-contact ultrasonic energy and oxygenated fluid irrigation. This is accomplished by the non-contact, non-thermal application of a fine oxygenated fluid stream spray to the wound bed whereby ultrasound energy is transmitted via the stream from the applicator tip to the wound tissue. Non-contact ultrasound provides cellular stimulation, increased blood flow, and reduced bioburden with much less pain or thermal-effect than competing direct contact ultrasound devices. The AS1000 uses continuous ultrasonic energy to oxygenate the fluid (typically sterile saline) into a solution stream and couple the delivery of ultrasonic energy via the stream to the treatment site.
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    K Number
    K050129
    Device Name
    CELLERATION MIST THERAPY SYSTEM 5.1
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2005-05-17

    (118 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
    Device Description
    MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic energy to atomize saline and deliver a continuous mist to the treatment site to promote wound healing.
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    K Number
    DEN040004
    Device Name
    CELLERATION MIST THERAPY SYSTEM
    Manufacturer
    CELLERATION
    Date Cleared
    2004-06-25

    (57 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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