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510(k) Data Aggregation

    K Number
    K073332
    Device Name
    V-RASER DIODE LASER SYSTEM
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2008-02-14

    (79 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041930,K063384
    Why did this record match?
    Device Name :

    V-RASER DIODE LASER SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.

    Specific Indications: Treatment of vascular lesions.

    Device Description

    The V-RASER Diode System is a modified Diodent Micro 980. It will use similar specifications (laser medium, excitation method, fiber optic beam delivery, electrical requirements, physical specifications) as the Diodent Micro 980. The laser source of this device is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 980-nanometer wavelength. The delivery system consists of removable flexible HCS (hard clad silica) optical treatment fiber assembly connected to a lightweight, hand piece that has two different size end pieces (tips) to adjust the laser beam to specific spot sizes. Activation occurs when the operator enables the laser by a key switch, enters the Ready Mode and presses the footswitch. Releasing the footswitch suspends laser treatment. A color LCD and touch-screen display panel allows the operator to adjust or set the laser output level. The laser operates in a pulsed mode and will have a removable stainless steel end piece for establishing the proper focal length for the treatment. The hand piece will be manually attached (i.e., screwed on) to a connector to the fiber assembly. The spot size will be selected on the control panel and the software will calculate the treatment fluence accordingly.

    AI/ML Overview

    The provided 510(k) summary for the V-RASER Diode Laser System does not contain information about acceptance criteria or a study proving the device meets them.

    Instead, it's a premarket notification for a medical device seeking substantial equivalence to a predicate device. The document explicitly states:

    • Nonclinical Performance Data: None
    • Clinical Performance Data: None

    Therefore, I cannot provide the requested information. This device was cleared based on its similarity to existing, legally marketed devices, rather than through a study demonstrating its performance against specific acceptance criteria.

    The information regarding the training set, test set, ground truth, expert qualifications, and adjudication methods is typically found in clinical or performance studies, which were not submitted for this 510(k) application.

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