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510(k) Data Aggregation

    K Number
    K981350
    Device Name
    ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES
    Manufacturer
    XINTEC CORPORATION
    Date Cleared
    1998-07-09

    (86 days)

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

    ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES

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

    The Alexis Alexandrite Laser System and accessories are indicated for: Cosmetic and Plastic Surgery Photocoagulation of dermatological vascular lesions Treatment of cutaneous vascular and pigmented lesions

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device (Alexis™ Alexandrite Laser System and Accessories). It approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information regarding acceptance criteria, study data, or performance metrics of the device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not on the technical performance specifications or the studies supporting those specifications.

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