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

    SUNETICS CLINICAL BIO-STIMULATION LASER

    K Number: K132646 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    116

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    Basic Information

    Device Name
    SUNETICS CLINICAL BIO-STIMULATION LASER
    K Number
    K132646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunetics International Marketing Group, LLC
    Date Received
    August 26, 2013
    Decision Date
    December 20, 2013
    Product Code
    OAP
    Advisory Committee
    Physical Medicine
    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
    OAP Laser, Comb, Hair

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    Other Clearances by Sunetics International Marketing Group, LLC

    K Number Device Name
    K121920 LASERBRUSH