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

    VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

    K Number: K061295 · Decision May 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    4
    Review Days
    16

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    Basic Information

    Device Name
    VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
    K Number
    K061295
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theralight, Inc.
    Date Received
    May 9, 2006
    Decision Date
    May 25, 2006
    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
    K051259 VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
    K024020 THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
    K022165 THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2