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

    SPECTRA HAIR REMOVAL LASER

    K Number: K053527 · Decision Feb 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    5
    Review Days
    774

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    Basic Information

    Device Name
    SPECTRA HAIR REMOVAL LASER
    K Number
    K053527
    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
    Spectragenics, Inc.
    Date Received
    December 19, 2005
    Decision Date
    February 1, 2008
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Spectragenics, Inc.

    K Number Device Name
    K090820 TRIA HAIR REMOVAL LASER SYSTEM
    K060567 SPECTRAGENICS ATS-1
    K052848 SPECTRA HAIR REMOVAL LASER
    K032846 SPECTRA PULSED DIODE LASER, MODEL DR-1