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

    Light based hair removal device

    K Number: K180383 · Decision May 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    Light based hair removal device
    K Number
    K180383
    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
    Shenzhen Gsd Tech Co., Ltd.
    Date Received
    February 12, 2018
    Decision Date
    May 11, 2018
    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 Shenzhen Gsd Tech Co., Ltd.

    K Number Device Name
    K230060 Light Based Hair Removal Device GP592
    K213225 Diode Laser System GP900A8, Diode Laser System GP900Q8
    K202827 308nm Excimer UV-light Skin Therapy System
    K191518 CO2 Laser System
    K142186 DIODE LASER HAIR REMOVAL SYSTEM
    K091664 GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C