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

    THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM

    K Number: K024020 · Decision Jan 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    4
    Review Days
    43

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    Basic Information

    Device Name
    THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
    K Number
    K024020
    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
    Theralight, Inc.
    Date Received
    December 5, 2002
    Decision Date
    January 17, 2003
    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 Theralight, Inc.

    K Number Device Name
    K061295 VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
    K051259 VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
    K022165 THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2