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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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The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M021-5AF/1
In Commercial Distribution

  • 03830054237629 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system
The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution

  • 03830054230507 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution

  • 03830054230194 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
  • Dental solid-state laser system
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS14
Not in Commercial Distribution

  • 10075289623568 ()
  • 00075289623561 ()
  • 00834533001766 ()

  • Absorbency


  • Incontinence pants, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS20
Not in Commercial Distribution

  • 10075289621922 ()
  • 00075289621925 ()
  • 00834533001759 ()

  • Absorbency


  • Incontinence pants, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS18
Not in Commercial Distribution

  • 10075289621717 ()
  • 00075289621710 ()
  • 00834533001742 ()

  • Absorbency


  • Incontinence pants, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESCSR20
Not in Commercial Distribution

  • 10075289002066 ()
  • 00075289002069 ()
  • 00834533001728 ()

  • Absorbency


  • Absorbent underpad, non-antimicrobial, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BCNAEZCSR02
Not in Commercial Distribution

  • 00834533001490 ()
  • 00834533000592 ()
  • 10834533000599 ()

  • Absorbency


  • Absorbent underpad, non-antimicrobial, single-use
No Description
Slow Wave, Inc.
AT
In Commercial Distribution

  • 00860007686610 ()
SWAT01

  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.
Trevi Technology, Inc.
AT
In Commercial Distribution

  • 00869228000441 ()


  • Ophthalmic tonometer, manual
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