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

    Silhouette Featherlift

    K Number: K171005 · Decision May 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    Silhouette Featherlift
    K Number
    K171005
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silhouette Lift, Inc.
    Date Received
    April 4, 2017
    Decision Date
    May 3, 2017
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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    Other Clearances by Silhouette Lift, Inc.

    K Number Device Name
    K200140 Silhouette Instalift
    K191299 Silhouette Featherlift / Silhouette Lift
    K163676 Silhouette InstaLift
    K142061 SILHOUETTE INSTALIFT