BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LymphaTech Mobile 3D Measuring Tool

    K Number: K251255 · Decision Jul 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    LymphaTech Mobile 3D Measuring Tool
    K Number
    K251255
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lymphatech, Inc.
    Date Received
    April 23, 2025
    Decision Date
    July 22, 2025
    Product Code
    SFG
    Advisory Committee
    General, Plastic Surgery
    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
    SFG Camera, Surgical, Measurement