Liftendo; Liftendo 2.0

Medical San Indústria DE Equipamentos Médicos Ltda.

Country / region:Brazil (BR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241771
Device name
Liftendo; Liftendo 2.0
Country / region
Brazil(BR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-20
Decision date
2024-09-16
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingVascular treatmentOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for 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.

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.

Summary parsed at:2026-06-01 05:28:48 UTC

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