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510(k) Data Aggregation

    K Number
    K250188
    Device Name
    Wound Treatment System (VHT-200)
    Manufacturer
    Date Cleared
    2025-03-10

    (47 days)

    Product Code
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vaporox, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
    Device Description
    The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.
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    K Number
    K212121
    Device Name
    VHT-200 Wound Treatment System
    Manufacturer
    Date Cleared
    2023-03-23

    (624 days)

    Product Code
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vaporox, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment. The VHT-200 wound treatment system is intended for the following kinds of wounds: - · skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions - decubitus ulcers - · amputations/infected stumps - · skin grafts - burns - · frostbite
    Device Description
    The VHT-200 Wound Treatment System is a prescription medical device. This system is designed for most topical skin injuries that can benefit from the properties of oxygen and moisture therapy treatments. All the benefits of oxygen and moisture modalities are self-contained into one system and applied without the need of switching applications. The VHT-200 is made for clinical office use. The VHT-200 wound treatment system is designed for the medical provider to add oxygen flow rate and frequency of the treatments based on experience and professional assessment of the individual patient's medical need.
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