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510(k) Data Aggregation

    K Number
    K251919
    Device Name
    Thulium Laser System (Deluxlase)
    Manufacturer
    Nanjing Bestview Laser S&T Co., Ltd.
    Date Cleared
    2025-09-26

    (95 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K223727
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Deluxlase is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

    Device Description

    Thulium Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a hand piece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The Thulium Laser System is equipped with a 650 nm aiming beam.

    AI/ML Overview

    N/A

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