BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Qraycam PRO

    K Number: K221275 · Decision Sep 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    856

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    Basic Information

    Device Name
    Qraycam PRO
    K Number
    K221275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AIOBIO Co., Ltd.
    Date Received
    May 2, 2022
    Decision Date
    September 4, 2024
    Product Code
    NBL
    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
    NBL Laser, Fluorescence Caries Detection

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    Other Clearances by AIOBIO Co., Ltd.

    K Number Device Name
    K183121 Qraypen