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

    PHOTOTHERAPEUTIX MODEL 800B

    K Number: K933952 · Decision Feb 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    6
    Review Days
    558

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    Basic Information

    Device Name
    PHOTOTHERAPEUTIX MODEL 800B
    K Number
    K933952
    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
    Avex Industries , Ltd.
    Date Received
    August 12, 1993
    Decision Date
    February 21, 1995
    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 Avex Industries , Ltd.

    K Number Device Name
    K935525 PHOTOTHERAPEUTIX MODEL 2480AB
    K933954 PHOTOTHERAPEUTIX MODEL 2400B
    K933953 PHOTOTHERAPEUTIX MODEL 1650B
    K935526 PHOTOTHERAPEUTIX MODEL 1600B
    K935524 PHOTOTHERAPEUTIX MODEL 3200A