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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
ALMA LASERS LTD.
01
In Commercial Distribution

  • 17290110121775 ()
AASP12091710

  • Radio-frequency skin/body contouring system
No Description
ALMA LASERS LTD.
01
In Commercial Distribution

  • 17290110121768 ()


  • Radio-frequency skin/body contouring system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121683 ()
AARF16091501SA0001

  • Ultrasonic skin/body contouring system
  • Radio-frequency skin/body contouring system
The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110122348 ()
AAAP07042215

  • Ultrasonic skin/body contouring system
  • Radio-frequency skin/body contouring system
The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110122331 ()
AAAP07042213

  • Ultrasonic skin/body contouring system
  • Radio-frequency skin/body contouring system
The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110122324 ()
AAAP07042211

  • Ultrasonic skin/body contouring system
  • Radio-frequency skin/body contouring system
The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110122317 ()
AAAP07042201BA0001

  • Ultrasonic skin/body contouring system
  • Radio-frequency skin/body contouring system
Precision Flow Oxygen Assist Module, NEL Unit Brazil
VAPOTHERM, INC.
PF-OAM-NEL-BR
In Commercial Distribution

  • 00841737105794 ()


  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
  • Respiratory oxygen therapy physiologic monitor/gas regulator
Precision Flow Oxygen Assist Module, MAS Unit Brazil
VAPOTHERM, INC.
PF-OAM-MAS-BR
In Commercial Distribution

  • 00841737105787 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Oxygen Assist Module, NEL UKIT Brazil
VAPOTHERM, INC.
PF-OAM-NEL-UKIT-BR
In Commercial Distribution

  • 00841737105770 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
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