BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇭🇰 Hong Kong

    Klinly Ultrasonic Tongue Cleaner

    K Number: K181986 · Decision Sep 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    408

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    Basic Information

    Device Name
    Klinly Ultrasonic Tongue Cleaner
    K Number
    K181986
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kea Products, Ltd.
    Date Received
    July 25, 2018
    Decision Date
    September 6, 2019
    Product Code
    QIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QIA Powered Tongue Scraper