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

    OMEGA EXCEL/XP LASER SYSTEM

    K Number: K043353 · Decision Jul 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    207

    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
    OMEGA EXCEL/XP LASER SYSTEM
    K Number
    K043353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Technologies, Inc.
    Date Received
    December 6, 2004
    Decision Date
    July 1, 2005
    Product Code
    NHN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

    Similar 510(k) Clearances

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

    MR5 Activ Pro

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Erchonia DPN Laser (Model# EVRL)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Therapy US

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Therapy EC, Therapy XT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Erchonia FX-405

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Advanced Medical Technologies, Inc.

    K Number Device Name
    K053473 MAESTRO MDTL LASER SYSTEM