BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

    K Number: K230720 · Decision Jul 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    48
    Applicant Total
    11
    Review Days
    109

    Basic Information

    Device Name
    LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
    K Number
    K230720
    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
    Light Tree Ventures Europe B.V.
    Date Received
    March 16, 2023
    Decision Date
    July 3, 2023
    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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