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

    Laser Hair Therapy

    K Number: K183329 · Decision Jan 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    47

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    Basic Information

    Device Name
    Laser Hair Therapy
    K Number
    K183329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omm Imports, Inc. D/B/A Zero Gravity
    Date Received
    November 30, 2018
    Decision Date
    January 16, 2019
    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 Omm Imports, Inc. D/B/A Zero Gravity

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