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510(k) Data Aggregation

    K Number
    K241771
    Device Name
    Liftendo; Liftendo 2.0
    Date Cleared
    2024-09-16

    (88 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical San Indústria de Equipamentos Médicos Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Liftendo 2.0 and Liftendo are intended for the delivery of laser light to soft tissue in contact mode and non-contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is also indicated for laser-assisted lipolysis. The device's 1470nm laser is intended for the delivery of laser light to soft tissue in non-contact mode during general surgical procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
    Device Description
    The Liftendo 2.0 and Liftendo are intended for the delivery of laser light to soft tissue in contact mode and non-contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is also indicated for laser-assisted lipolysis. The device's 1470nm laser is intended for the delivery of laser light to soft tissue in non-contact mode during general surgical procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
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    K Number
    K231901
    Device Name
    Hakon, Hakon Smart
    Date Cleared
    2023-09-28

    (92 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical San Indústria de Equipamentos Médicos Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dermatological Diode Laser (Model: Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
    Device Description
    The Hakon and Hakon Smart device is a micro-controlled equipment used in diode laser therapies at wavelengths of 808nm intended to remove unwanted hair.
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