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

    PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT

    K Number: K913760 · Decision Oct 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    5
    Review Days
    67

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    Basic Information

    Device Name
    PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
    K Number
    K913760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Psoralite Corp.
    Date Received
    August 22, 1991
    Decision Date
    October 28, 1991
    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
    K890084 PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
    K881385 PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL
    K864510 PSORALITE 12800 SERIES
    K864511 PSORALITE 18400 SERIES