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510(k) Data Aggregation
K Number
K231628Device Name
BeShape One Device
Manufacturer
BeShape Technologies Ltd.
Date Cleared
2023-09-29
(116 days)
Product Code
OHV
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
BeShape Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BeShape One™ device delivers High Intensity, Non-Focused Ultrasound energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.
Device Description
The BeShape One™ device is a non-invasive, high intensity, non-focused US device intended for disruption of the subcutaneous adipose tissue and indicated for noninvasive waist circumference reduction. The BeShape One™ device utilizes continuous wave (CW) ultrasonic energy applied to the adipose tissue at a temperature of 47-49ºC. A cooling system maintains the skin temperature at below 35℃. The device consists of hardware and software. These elements are integrated in the BeShape One™ console and applicator/hand piece. BeShape One™ is supplied as a console and two identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.
The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:
- Power Source
- Controller unit (CPU) .
- Water cooling system (Chiller) ●
- Vacuum System
- . Block Amplifier
- Touchscreen display monitor ●
- Personal computer and proprietary software .
- Two designated applicator cradles .
- Two designated applicator connector ports .
The BeShape One™ device applicator is a mechanical handpiece with an internal rectangular bathtub-shaped chamber and consists of the following elements:
- Two parallel facing US transducers Each transducer includes four piezoelectric . (PZT) ceramic elements which convert electrical energy into acoustic energy in the ultrasound frequency range. Each transducer can transmit up to 1.5W/cm2 of acoustic energy at a frequency of 2MHz.
- . Vacuum - The vacuum provides effective fixation of the adipose tissue under the skin in the cup-shaped chamber of the Applicator.
- The cooling system which includes thermoelectric coolers (TEC) for ultrasound ● (US) transducers (TD) and a water-cooling system for the hot side of the thermoelectric coolers (TEC). The cooling system is intended to cool the applicator and skin to below 35°C.
The Applicator uses vacuum during the procedure, which draws adipose tissue under the skin into the inner cup-shaped chamber, thereby heating the subcutaneous adipose tissue.
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