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510(k) Data Aggregation

    K Number
    K030897
    Device Name
    SKINSTATION
    Manufacturer
    RADIANCY (ISRAEL) LTD.
    Date Cleared
    2003-06-19

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K031853,K023605,K002347,K031024
    Predicate For
    K033181,K040659,K041554,K043255,K050950,K052336,K063060,K073317,K091664
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

    Device Description

    The SkinStation is a pulsed light device intended for hair removal and treatment of pigmented and vascular lesions. When operated in the hair removal mode, the Skin Station is identical to the previously cleared SpaTouch, except that it is now housed with the SPR module for treating pigmented and vascular lesions. When operated in the pigmented and vascular lesions mode (i.e., using the SPR handpiece), the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the cleared Quantum, with a few exceptions which do not raise new issues of safety and effectiveness. In addition, the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the previously cleared MBC's Prolite and Palomar's EsteLux when operated in the SPR mode

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study to prove the device meets acceptance criteria. The document is a 510(k) summary for the Radiancy SkinStation™ System, primarily discussing its substantial equivalence to predicate devices for its intended use of hair removal and treatment of pigmented and vascular lesions. It does not detail specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.

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