BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LightStim Professional 2-Panel Light

    K Number: K151336 · Decision Oct 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    11
    Review Days
    157

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    Basic Information

    Device Name
    LightStim Professional 2-Panel Light
    K Number
    K151336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Led Intellectual Properties, LLC
    Date Received
    May 19, 2015
    Decision Date
    October 23, 2015
    Product Code
    OHS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OHS Light Based Over The Counter Wrinkle Reduction

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    Other Clearances by Led Intellectual Properties, LLC

    K Number Device Name
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    K142246 LightStim for Acne/ LightStim for Acne Mini
    K131461 LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
    K120775 LIGHT FOR WRINKLES
    K101190 LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
    K092800 ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
    K083580 ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
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