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510(k) Data Aggregation

    K Number
    K090281
    Device Name
    ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
    Manufacturer
    ACCUTECH MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2009-03-04

    (27 days)

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

    ACCUTECH MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
    Device Description
    The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type): Bare Fibers - No Sheaths - Glass fiber optic with jacket - SMA connector Bare Fibers - With Sheaths - Glass fiber optic with jacket - Sheath - SMA connector SideFire Fibers - Glass fiber optic with jacket with distal (patient contact) fiber tip encased in glass capillary tube - SMA connector - Adjustable handle (tightens on fiber to allow user to direct laser energy to desired target site) Endoprobes/ ENT Fibers - A glass fiber optic protected by a medical grade stainless steel needle/ cannula (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end - SMA connector Additional Accessory(ies) - Optional Radiofrequency identification (RF ID) connector for use with INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)
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    K Number
    K061025
    Device Name
    ACCUTECH ENDOLITE PROBE
    Manufacturer
    ACCUTECH MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2006-05-31

    (48 days)

    Product Code
    FFS, GEX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCUTECH MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology. The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.
    Device Description
    The Accutech EndoLite Probe is comprised of the following main components: - A glass fiber optic protected by a medical grade stainless steel needle and handle at . the distal (patient contact) end and by a plastic jacket at the proximal (laser connection) end; and - . A universal SMA laser connector. The Accutech EndoLite Probe is provided as a sterile, single use 532-659 nm laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the compatible 532-659 nm laser system with universal SMA compatibility that has been qualified by Accutech Medical Technologies, Inc. for use with the Accutech EndoLite Probe.
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