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510(k) Data Aggregation
K Number
K134040Device Name
BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
Manufacturer
BTL INDUSTRIES LTD
Date Cleared
2014-09-10
(253 days)
Product Code
OLI
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
BTL INDUSTRIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
Device Description
The BTL-9000 consists of a control unit, connection lead to a BTL-9000 Laser Applicator and other accessories. (A full list of system contents is included in the operator's manual). The Laser Applicator is containing four cold red (660 nm) laser-emitting diodes and is designed to be placed on the skin. The output of the diode (four per applicator) is limited to 50mW ± 15% by a power limiting PCB from the central processing unit. The system can operate using 1 applicator that is connected to the control unit. The control unit is an electrically powered unit (100-240V, 50-60Hz auto-ranging). Once enabled it is controlled using a touchscreen interface. When the Laser Applicator is placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells and therefore reduced in size. The BTL-9000 is a stand-alone device which can be used together with other modalities which are not part of this submission.
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K Number
K122966Device Name
XP200
Manufacturer
BTL INDUSTRIES LTD
Date Cleared
2013-04-08
(195 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BTL INDUSTRIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids.
Device Description
The XP200 system is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field. The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the onscreen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the set power, and other necessary data. The XP200 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator with color screen and control buttons.
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K Number
K092191Device Name
EXILIS, MODEL 5000
Manufacturer
BTL INDUSTRIES LTD
Date Cleared
2009-11-25
(127 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BTL INDUSTRIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
Device Description
The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device is equipped with a stylus (touch pen) for comfortable control of the touch screen. The vertically oriented design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the surgery. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters.
Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data.
The EXILIS device enables to insert the patient's name and additional corresponding information in its internal memory and link these data with the pre-defined or customer protocols. At the patient's next visit simply call his/her name on the device and apply the preset therapy. The EXILIS device is placed in a specially designed cart, the shape of which provides the maximum comfort of the handling and use of the device. Four stable castors ensure easy moving of the device in the office or surgery.
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