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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 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
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
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906622476 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906630969 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906630952 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906630945 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906630938 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906630921 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06934906630914 ()


  • Dental appliance fabrication material, ceramic
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