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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?
Applicant Name (Manufacturer) :
OSYRIS MEDICAL
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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K Number
K082004Device Name
SMOOTHKIT+
Manufacturer
OSYRIS
Date Cleared
2008-09-26
(74 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OSYRIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SMOOTHKIT+ is intended for laser assisted lipolysis.
Device Description
SMOOTHKIT+ is a medical laser accessory. It includes a cannula crimped on an optical fiber and a handpiece. The extremity of the cannula is sharp edges rounded. The extremities of the cannula and of the optical fiber are in the same plan and there is some adhesive between the cannula and the fiber at the distal end.
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K Number
K080731Device Name
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
Manufacturer
OSYRIS
Date Cleared
2008-07-17
(125 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OSYRIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs.
Device Description
The medical device PHARAON 980 is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. PHARAON 980 includes the whole of the supplies necessary to supply the laser and to ensure its thermalisation using a Peltier element built on a ventilated radiator.
PHARAON 980 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 TFT screen and a tactile flagstone.
PHARAON 980 is available for ENDO application (endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux) and EXO application (photocoagulation of teleangectasia of the legs).
PHARAON 980 EXO is supplied with CONTROL4+ HANDPIECE a dedicated handpiece including an auto-requlated cooling system and video allowing optimal mapping of the treatment area and screen display of the vessel on PHARAON 980.
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K Number
K073617Device Name
PHARAON LIPO
Manufacturer
OSYRIS
Date Cleared
2008-04-09
(105 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OSYRIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PHARAON LIPO is intended for laser assisted lipolysis
Device Description
The medical device PHARAON LIPO is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm 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 fiber of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.
In addition PHARAON LIPO 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 TFT screen and a tactile flagstone.
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