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 Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution

  • 04049471095074 ()

  • Weight: 295 Kilogram
  • x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m


  • Ophthalmic excimer laser system
5.0cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
750
In Commercial Distribution

  • 00376128000391 ()

  • Length: 5.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
3.0cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
730
In Commercial Distribution

  • 00376128000384 ()

  • Length: 3.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
2.5cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
725
In Commercial Distribution

  • 00376128000377 ()

  • Length: 2.5 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
2.0cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
720
In Commercial Distribution

  • 00376128000360 ()

  • Length: 2.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
1.5cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
715
In Commercial Distribution

  • 00376128000353 ()

  • Length: 1.5 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
1.0cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
710
In Commercial Distribution

  • 00376128000346 ()

  • Length: 1.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
3.0cm rigid fiber optic diffuser for use in photodynamic therapy.
Pinnacle Biologics, Inc.
230
In Commercial Distribution

  • 00376128000278 ()

  • Length: 3.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
5.0cm rigid fiber optic diffuser for use in photodynamic therapy.
Pinnacle Biologics, Inc.
250
In Commercial Distribution

  • 00376128000261 ()

  • Length: 5.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
2.5cm rigid fiber optic diffuser for use in photodynamic therapy.
Pinnacle Biologics, Inc.
225
In Commercial Distribution

  • 00376128000254 ()

  • Length: 2.5 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
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