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

    MIDI-SRS

    K Number: K141046 · Decision Dec 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    245

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MIDI-SRS
    K Number
    K141046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Srmc Co., Ltd.
    Date Received
    April 23, 2014
    Decision Date
    December 24, 2014
    Product Code
    ONG
    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
    ONG Powered Laser Surgical Instrument With MicrobeamFractional Output

    Similar 510(k) Clearances

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

    AVAVA™ Skin Treatment System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    eCO2 3D

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Fiber Laser Treatment Systems (HS-232,HS-233)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AVAVA™ Skin Treatment System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MOSAIC 3D (Surgical Laser)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Miria Skin Treatment System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all