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
Product code
GEX
21 CFR 878.4810
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
Predicate devices
1Diode laser therapy device
K241771 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241771 as a predicate