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510(k) Data Aggregation
K Number
K212969Device Name
Liposaver
Manufacturer
LHbiomed Co., Ltd.
Date Cleared
2024-08-07
(1056 days)
Product Code
QPB, MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
LHbiomed Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LipoSaver™ is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. LipoSaver™ is indicated for use in the following surgical specialists when the fragmentation and aspiration of soft tissue is desired:
- Plastic and Reconstruction Surgery
- Orthopedic Surgery
Device Description
LS-1000/LS-2000 is an ultrasonic surgical unit which uses ultrasound frequency vibration to fragment, emulsify subcutaneous fatty tissues. The PZT ceramic crystals in handpiece of LS-1000/LS-2000 transforms electrical signal into ultrasonic vibrations, and these vibrations transmit to the probe of LS-1000/LS-2000 which performs the function of fragmenting and emulsifying the subcutaneous fatty tissues. The LS-1000/LS-2000 is able to adjust the operating features such as vibration amplitude and frequency, and provides two modes as follows:
- N mode (continuous mode)
- Z mode (pulsed mode)
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