BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

    K Number: K232117 · Decision Nov 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    5
    Review Days
    134

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    Basic Information

    Device Name
    Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
    K Number
    K232117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuhan Lotuxs Technology Co., Ltd.
    Date Received
    July 17, 2023
    Decision Date
    November 28, 2023
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Wuhan Lotuxs Technology Co., Ltd.

    K Number Device Name
    K231910 DermRays Revive
    K230090 Diode Laser Hair Removal
    K191068 Powersculp laser lipolysis system
    K142845 SILKPRO laser hair removal system