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510(k) Data Aggregation

    K Number
    K182498
    Device Name
    Advanced Skin Renewing Device
    Manufacturer
    Jiangsu Unimed Laser Technology Co., Ltd.
    Date Cleared
    2018-11-30

    (79 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Unimed Laser Technology Co., Ltd.

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

    Advanced Laser Device is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.

    Device Description

    Advanced Laser Device

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "Advanced Laser Device," which largely focuses on regulatory compliance and the device's substantial equivalence to predicate devices. It includes the Indications for Use for the device but no details about performance specifications or clinical study results.

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