BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    dermalux Flex MD

    K Number: K202028 · Decision Dec 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    423
    Registration Numbers
    423
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    147

    Basic Information

    Device Name
    dermalux Flex MD
    K Number
    K202028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesthetic Technology Ltd
    Date Received
    July 22, 2020
    Decision Date
    December 16, 2020
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    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
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Aesthetic Technology Ltd

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