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Found 3 results
510(k) Data Aggregation
K Number
K100230Device Name
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
Manufacturer
ELEME MEDICAL, INC.
Date Cleared
2010-04-02
(66 days)
Product Code
NUV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ELEME MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.
Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).
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K Number
K083478Device Name
SMOOTHLIPO
Manufacturer
ELEME MEDICAL, INC.
Date Cleared
2009-03-17
(113 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ELEME MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SMOOTHLIPO is intended for laser-assisted lipolysis
Device Description
The SMQQTHLIPO is the medical laser device using a diode laser module with 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 with the core of 600um. The optical fiber is connected to the laser module via a SMA 905 connector. The SMOOTHLIPO laser includes power supply for the laser (50A, 2V) and a Peltier element built on a ventilated radiator for efficient functioning of the device.
In addition, functional electronics is provided to allow for laser parameter setting and the safe functioning of the device. The adjustments of parameters is achieved through a TFT (touch) screen and a tactile flagstone.
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K Number
K083629Device Name
SMOOTHSHAPES
Manufacturer
ELEME MEDICAL, INC.
Date Cleared
2009-02-19
(73 days)
Product Code
NUV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ELEME MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Elemé Medical SmoothShapes® system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The SmoothShapes® System featuring Photomology® technology is designed to offer an innovative way to safely and effectively treat cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to reduce the appearance of cellulite.
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