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510(k) Data Aggregation

    K Number
    K041957
    Device Name
    EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
    Manufacturer
    DIOMED, INC.
    Date Cleared
    2004-12-01

    (133 days)

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

    DIOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
    Device Description
    The DIOMED 15 Plus is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The DIOMED 30 Plus is a diode laser capable of delivering up to 400 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-30 W of continuous wave radiation via an optical fiber coupled to the laser aperture. An EVLT procedure kit is available which may contains a 400 -1000 micron corc, 2.5 meter long bare tip fiber with location markers, a 25-100 cm long, 4- 5 Fr graduated introducer sheath with dilator, a 19 Gauge, 7 cm percutaneous entry needle, and a 0.035" J guide wire.
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    K Number
    K023543
    Device Name
    EVLT KIT AND D15PLUS AND D30PLUS DIODE
    Manufacturer
    DIOMED, INC.
    Date Cleared
    2002-12-02

    (41 days)

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

    DIOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EVLT kits and Diomed D15plus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein
    Device Description
    Not Found
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    K Number
    K013499
    Device Name
    DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
    Manufacturer
    DIOMED, INC.
    Date Cleared
    2001-11-16

    (25 days)

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

    DIOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diomed 15plus and Diomed 30plus Lasers are intended for use in delivering 15 or The Diomed reports wave radiation to a flexible optical fiber or spot hand piece for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures. The Diomed 15plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue applications: - General Surgery . - Ophthamology/Oculoplastic . - Urology - Gastroenterology - Gynecology - Otorhinolaryngology - Pulmonary/Thoracic - Dermatology/Plastic Surgery - Neurosurgery (coagulation only) - Orthopedic
    Device Description
    The Diomed 15plus and Diomed 30plus Lasers are modified versions of the Diomed 15 and Diomed 30 lasers. A shorter pulse duration (50 ms) has been added to both the 15plus and 30plus lasers. The modified devices include a spot handpiece/software delivery system in addition to a fiber delivery system. A Fluence Display has been added to enhance the efficiency of existing clinical indications when using the spot hand piece. A power meter (currently used in the Diomed 30 laser) has been added to the Diomed 15plus laser to improve the accuracy of delivered powcr/fluence to the treatment site.
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    K Number
    K000982
    Device Name
    A100 AESTHETIC DIODE LASER
    Manufacturer
    DIOMED, INC.
    Date Cleared
    2000-05-01

    (35 days)

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

    DIOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990014
    Device Name
    DIOSCAN
    Manufacturer
    DIOMED, INC.
    Date Cleared
    1999-02-26

    (53 days)

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

    DIOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
    Device Description
    The DioScan Scanning Handpiece is intended to allow the rapid treatment of a large area of skin by scanning a laser spot over a treatment area. The area treated allows the majority of the operator's time to be spent in treatment, with a small proportion of time spent in moving the scanner between areas. To minimize patient discomfort and reduce spent in moving the counter ous, the handpiece employs a cooled sapphire window in thermal contact with the skin during treatment.
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