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

    SILKPRO laser hair removal system

    K Number: K142845 · Decision Jul 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    274

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    Basic Information

    Device Name
    SILKPRO laser hair removal system
    K Number
    K142845
    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
    September 30, 2014
    Decision Date
    July 1, 2015
    Product Code
    OHT
    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
    OHT Light Based Over-The-Counter Hair Removal

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    Other Clearances by Wuhan Lotuxs Technology Co., Ltd.

    K Number Device Name
    K231910 DermRays Revive
    K232117 Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
    K230090 Diode Laser Hair Removal
    K191068 Powersculp laser lipolysis system