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

    TL100W/12

    K Number: K922963 · Decision Sep 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    6
    Review Days
    75

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    Basic Information

    Device Name
    TL100W/12
    K Number
    K922963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Lighting Co.
    Date Received
    June 19, 1992
    Decision Date
    September 2, 1992
    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 Philips Lighting Co.

    K Number Device Name
    K021514 PHILIPS PLS9W/12/2P UVB
    K021092 PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
    K940672 CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL
    K935840 TL 20W/12/RS & TL 40W/12/RS
    K910767 TL100W/01 UVB LAMP