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510(k) Data Aggregation

    K Number
    K091323
    Device Name
    MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
    Manufacturer
    INTERMEDIC ARFRAN, S.A.
    Date Cleared
    2009-06-04

    (30 days)

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

    INTERMEDIC ARFRAN, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
    Device Description
    The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components: - Laser console with fiber port and RF ID bracket - Operating software - Detachable footswitch - Delivery device accessories (fiber optic, handpieces and scanner)
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    K Number
    K053540
    Device Name
    INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE
    Manufacturer
    INTERMEDIC ARFRAN, S.A.
    Date Cleared
    2006-09-06

    (260 days)

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

    INTERMEDIC ARFRAN, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in coniunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
    Device Description
    The INTERmedic Diode Laser Family is designed to deliver laser power at wavelengths of 810nm and 980nm, depending on model, that can be used for the procedures indicated in the section "Indication for Use" in this summary. The ContrÂge model can be used with or without the RF unit. The different models can be identified by their different names, output frequency and maximum power. Each system is comprised with the following main components: Operating software controlled by a microprocessor, A footswitch (detachable), A laser cabinet/console with fiber port, A safety Interlock.
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