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510(k) Data Aggregation

    K Number
    K133774
    Device Name
    ATOVEN
    Manufacturer
    BIO-MED U.S.A., INC.
    Date Cleared
    2014-06-06

    (176 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MED U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins associated with varicose veins and varicosities. Non-Contact mode ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and variosities. Non-Contact mode
    Device Description
    ATOVEN Diode laser systems are Laser Surgery Systems that use optical energy radiated from semiconductor laser in order to cure varices. with Wave Length 1,470mm, and consists of CPU, LCD monitor, Cooling Systems, laser controller, Fiber optic pullback device included foot pedal switch. LED monitor are displaying various graphic to shows Operating Parameter, Mode, Time function, system status to user.
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    K Number
    K111831
    Device Name
    MX-7000 MICROXEL
    Manufacturer
    BIO-MED U.S.A., INC.
    Date Cleared
    2011-12-19

    (174 days)

    Product Code
    ONG, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MED U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MX-7000 CO2 laser system is indicated for use in non-fractionated mode is Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry. When used in fractionated mode, the MX-7000 CO2 system is indicated for use ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in Dermatology, Plastic surgery, and in General surgery.
    Device Description
    MX-7000 Laser system utilize a Co2 module to generate a laser beam with wave length of 10.600 nm and used fractional or non fractional mode for different indication. The Doctor can optimize the effect for different applications by controlling the power of laser pulse and using different hand pieces. The system are supplied with two hand pieces ( Scanned or/and Dynamic),depend the device configuration This system consist of Optic main Bench assembly, Articulated Arm LCD control panel, Laser Cooling system Hand pieces set, Foot Pedal switch.
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    K Number
    K081547
    Device Name
    BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
    Manufacturer
    BIO-MED U.S.A., INC.
    Date Cleared
    2008-09-08

    (98 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MED U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single use, sterile, intended use for the subcutaneous injection of U-100 Insulin only.
    Device Description
    "Bio-Med® Soft" Insulin syringe are sterile, single use, disposable hypodermic syringes with a permanently affixed lumen needle to the tip of syringe. The syringe consists of a barrel, a plunger rod with Synthetic Rubber Gasket, and an orange colored end-cap over the needle to preserve sterility of the fluid path. In addition the "Bio-Med® Soft" Insulin syringe are non-toxic and pyrogenic free "Bio-Med® Soft" Insulin syringe are available 1.0cc (100units), 0.5cc (50units), 0.3cc (30 units) with 29G, 30G, 31G, needle thickness, 1/2:'', 5/16'' needle length, and meet the following standard: ISO 7864 Sterile, Hypodermic Needles for single use ISO 8537: 1991/Amendment 1: 2000 Sterile, Single use Syringe with/without needle For insulin
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