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 Class Implantable

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No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110120112 ()
AAAE21111001

  • Ultrasonic hyperthermia system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110120105 ()
AAAE21111002

  • Ultrasonic hyperthermia system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110120099 ()
AAAE21111004

  • Ultrasonic hyperthermia system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110120082 ()
AASR07031307

  • Ultrasonic hyperthermia system
The Alma Lasers Soprano Titanium Laser System consists of: •System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts) •Operator control panel with touch-screen technology (GUI) •Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously Premarket Notification Traditional 510(k) Section 8: Page 2 of 4 Alma Lasers Soprano Titanium • 810 nm applicator • 755 nm applicator • Small NIR applicator • Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121829 ()
AASP05091845BSR0001

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121812 ()
AASP30111208

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121676 ()
AAIR02031605

  • Multi-modality skin surface treatment system
Nir Face (6) HP for Soprano Ice Platinum Edition\Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121669 ()
AAIR02031604

  • Multi-modality skin surface treatment system
Diode 810nm Speed 2cm HP for Soprano Ice Platinum Edition / Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121652 ()
AASP30111205

  • Dermatological diode laser system
Diode 755nm Alex 1.5cm HP for Soprano Ice Platinum Edition/Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121645 ()
AASP02031603

  • Dermatological diode laser system
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