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510(k) Data Aggregation

    K Number
    K163676
    Device Name
    Silhouette InstaLift
    Manufacturer
    SILHOUETTE LIFT, INC.
    Date Cleared
    2017-06-16

    (171 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILHOUETTE LIFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
    Device Description
    The Silhouette Instalift device consists of two Stainless Steel Surgical needles and an absorbable implant. The absorbable implant is available in three configurations, each consisting of a single monofilament that holds two bidirectional sets of 4, 6 or 8 cones. Both the monofilament and the cones are made from L- lactide/Glycolide bioresorbable resin material. This device is supplied sterile for single use only.
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    K Number
    K142061
    Device Name
    SILHOUETTE INSTALIFT
    Manufacturer
    SILHOUETTE LIFT, INC.
    Date Cleared
    2015-04-24

    (268 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILHOUETTE LIFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silhouette Instalift device is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.
    Device Description
    Not Found
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