BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇺🇸 United States

    SPERTILITE PHOTOTHERAPY LAMP

    K Number: K862608 · Decision Aug 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    SPERTILITE PHOTOTHERAPY LAMP
    K Number
    K862608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Cooper-Hewitt Electric Co.
    Date Received
    July 8, 1986
    Decision Date
    August 6, 1986
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Cooper-Hewitt Electric Co.

    K Number Device Name
    K860132 AIR CARE AIR SANITIZER
    K813047 AQUANOMICS, MINI 60L
    K813045 AQUANOMICS, #SP36SF
    K813046 AQUANOMICS, #HHU60
    K813049 AQUANOMICS, #HHU100
    K813048 AQUANOMICS, #MP2SF
    K813050 AQUANOMICS, #MP4SF