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510(k) Data Aggregation

    K Number
    K250998

    Validate with FDA (Live)

    Device Name
    CO2 Laser Therapy System (Model: LFS-D9U)
    Manufacturer
    Sanhe Lefis Electronics Co., Ltd.
    Date Cleared
    2025-12-19

    (262 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K201109,K162169,K191518
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K201109, K162169

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

    The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.

    Device Description

    CO2 Laser Therapy System (Model: LFS-D9U) uses infrared beam with a wavelength of 10.6 µm for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. The device comprises a main unit, therapy head, light guide system, and footswitch.

    AI/ML Overview

    N/A

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