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

    QUANTUM WARP 10 LIGHT DELIVERY SYSTEM

    K Number: K032229 · Decision Sep 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    53

    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
    QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
    K Number
    K032229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantum Devices, Inc.
    Date Received
    July 21, 2003
    Decision Date
    September 12, 2003
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

    Similar 510(k) Clearances

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

    CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LED Lip Perfector, model: ZC-05

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OLIZ LTB-1000A

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CytonPro-5000

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

    Other Clearances by Quantum Devices, Inc.

    K Number Device Name
    K113231 WARP10,WARP75