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

    PHILIPS PLS9W/12/2P UVB

    K Number: K021514 · Decision May 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    6
    Review Days
    7

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    Basic Information

    Device Name
    PHILIPS PLS9W/12/2P UVB
    K Number
    K021514
    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
    May 9, 2002
    Decision Date
    May 16, 2002
    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
    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
    K922963 TL100W/12
    K910767 TL100W/01 UVB LAMP