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

    Capillus302, Capillus312, Capillus352

    K Number: K162994 · Decision Nov 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    22

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    Basic Information

    Device Name
    Capillus302, Capillus312, Capillus352
    K Number
    K162994
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Capillus, LLC
    Date Received
    October 27, 2016
    Decision Date
    November 18, 2016
    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 Capillus, LLC

    K Number Device Name
    K163170 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
    K160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
    K153618 Capillus202
    K151516 Capillus82
    K150578 Capillus 272 Office Pro
    K143199 Capillus 272 Pro