BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    NO!NO! SKIN

    K Number: K102477 · Decision Oct 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    11
    Review Days
    35

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    Basic Information

    Device Name
    NO!NO! SKIN
    K Number
    K102477
    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
    Radiancy (Israel) , Ltd.
    Date Received
    August 30, 2010
    Decision Date
    October 4, 2010
    Product Code
    OLP
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

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    Other Clearances by Radiancy (Israel) , Ltd.

    K Number Device Name
    K082423 NO!NO! SKIN
    K072331 RADIANCY MISTRAL DEVICE
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    K052991 RADIANCY FACIAL SKINCARE DEVICE
    K052442 RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
    K051671 RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY
    K032205 RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
    K033181 SPR SYSTEM
    K030897 SKINSTATION
    K020856 SPATOUCH PHOTOEPILATION SYSTEM
    Search all 11 clearances from Radiancy (Israel) , Ltd. →