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510(k) Data Aggregation

    K Number
    K042496
    Date Cleared
    2004-11-02

    (49 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue. Examples include: Telangiectasia Spider Naevi Angioma Hemangioma Leg veins (small, superficial) Epidermal Naevi Lentigines (solar and senile) Verrucae Vulgares (Warts) Cherry Angioma Port Wine Stain

    Device Description

    The Adept UltraLite 532 Laser is a diode laser which emits coherent light at 532 nm. The Ultralight 532 is a diode pumped solid state frequency doubled laser appliance.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for the Adept UltraLite 532 Laser, focusing on its substantial equivalence to predicate devices rather than performance data or analytical/clinical study results.

    Specifically, the document states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the UltraLite 532 and the claimed predicates, i.e., the BeautyStar 532 and DioLite 532 lasers."

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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