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510(k) Data Aggregation
K Number
K241771Device Name
Liftendo; Liftendo 2.0
Date Cleared
2024-09-16
(88 days)
Product Code
Regulation Number
878.4810Why 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
K231901Device Name
Hakon, Hakon Smart
Date Cleared
2023-09-28
(92 days)
Product Code
Regulation Number
878.4810Why 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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