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510(k) Data Aggregation

    K Number
    K242688
    Device Name
    Finiff System
    Manufacturer
    Date Cleared
    2024-12-20

    (105 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skingrab Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finiff System is intended for use in Dermatologic and General Surgery procedures that require electrocoagulation and hemostatis.
    Device Description
    The Finiff System is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The Finiff System consists of a console that houses an RF generator as well as the electronics. The user interface is a touchscreen that is located on the console. There are two handpieces that attach to the console: • The VertoRF Handpiece is a microneedling handpiece that delivers energy in 2 frequencies: 1mHz and 2mHz. The VertoRF has one disposable tip configuration that consists of 25 needles and penetrates the tissue up to 4mm in depth. • Ther VitaRF Handpiece delivers noninvasive RF energy at a frequency of 6.78 MHz. The VitaRF handpice has 2 Treatment Tips: the VitaRF F-Tip and the VitaRF E-Tip In addition to the console and the 2 handpieces, there are accessories as follows: • Power Cord • Footswitch (optional) • Cryogen canister • Return Pad • Coupling fluid
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