BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Surgical Microscope (OMS2360, OMS2380)

    K Number: K252464 · Decision Apr 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    265

    Basic Information

    Device Name
    Surgical Microscope (OMS2360, OMS2380)
    K Number
    K252464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zumax Medical Co., Ltd.
    Date Received
    August 6, 2025
    Decision Date
    April 28, 2026
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NBL), ordered by most recent decision date.

    TRIOS Ready Tip

    FDA 510(k)
    FDA Class 2 ·Dental

    Qraycam PRO

    FDA 510(k)
    FDA Class 2 ·Dental

    SmarTooth

    FDA 510(k)
    FDA Class 2 ·Dental

    C50

    FDA 510(k)
    FDA Class 2 ·Dental

    L1P-1F (TRIOS 5)

    FDA 510(k)
    FDA Class 2 ·Dental

    IC-WHCD100 (Inspire)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all