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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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CM4 220, THERAPY HAMMER, LASER MODULE, 1 CASE OF 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTORS
COMPASS HEALTH BRANDS CORP.
410-012
Not in Commercial Distribution

  • 00852515007285 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM4 220, THERAPY HAMMER, AUTOSOUND, LASER MODULE, 1 CASE OF 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTORS
COMPASS HEALTH BRANDS CORP.
410-012-220
Not in Commercial Distribution

  • 00852515007278 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
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
Glide Disposable Tip Set of 12 units
ALMA LASERS LTD.
1
Not in Commercial Distribution

  • 17290110122208 ()
AAOP08121911

  • Radio-frequency skin/body contouring system
Glide Disposable Tip one pc.
ALMA LASERS LTD.
1
Not in Commercial Distribution

  • 17290110122192 ()
AARF15112101

  • Radio-frequency skin/body contouring system
Opus Colibri 1mm Single-use Tip one unit
ALMA LASERS LTD.
1
Not in Commercial Distribution

  • 17290110122185 ()
AACL03052002

  • Radio-frequency skin/body contouring system
Opus Colibri 0.7mm Single-use Tip one ubit
ALMA LASERS LTD.
1
Not in Commercial Distribution

  • 17290110122178 ()
AACL03052001

  • Radio-frequency skin/body contouring system
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