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

    PSORALITE 12800 SERIES

    K Number: K864510 · Decision Feb 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    PSORALITE 12800 SERIES
    K Number
    K864510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Psoralite Corp.
    Date Received
    November 14, 1986
    Decision Date
    February 4, 1987
    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 Psoralite Corp.

    K Number Device Name
    K913760 PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
    K890084 PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
    K881385 PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL
    K864511 PSORALITE 18400 SERIES