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510(k) Data Aggregation
K Number
K090754Device Name
LIPOCONTROL
Manufacturer
OSYRIS MEDICAL
Date Cleared
2011-01-21
(672 days)
Product Code
ORK, GEX
Regulation Number
878.4810Why did this record match?
Product Code :
ORK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LIPOCONTROL is indicated for: Laser assisted lipolysis. LIPOCONTROL should be used to melt small amount of fat from small areas only such as chins or upper arms. LIPOCONTROL should not be used to melt larger volumes or areas of fat and on areas such as thighs, buttocks, or abdomen.
Device Description
The medical device LIPOCONTROL is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ±10nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fibre of 200um or more. The optical fibre is screwed onto the SMA 905 connector of the laser module. LipoControl contains a localisation system. This localisation system is based on a magnetic sensor (LipoBird), positioned on the handpiece and a field transmitter. With this localization system, an informative function and a safety function are built-in: The informative function is a 2D map (display on the device screen) which indicates the area where the energy is deposited and the total amount of energy delivered. The safety function is on the delivered power. Maximum output power and output fiber speed displacement are chosen by physician and delivered when footswitch is pressed and the output fiber speed displacement is over the pre-defined limit. If it the output fiber speed displacement is below the pre-defined limit then the delivered power is diminished. The 2D map can be displayed only if the treatment surfaces are inclined less than 35 decree relative to the observation plane defined by the user. The user can divide the treated area in adiacent areas with an andle less than 35 degree or use the device without these optional functions. The LipoControl includes the power supplies necessary to supply the laser and to ensure its temperature control using Peltier elements built on a ventilated radiator. In addition, the LIPOCONTROL includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a LCD (Liquid Crystal Display) screen and a touch screen controlled by a PC.
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