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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Stimulation Ground Cables
AXONICS MODULATION TECHNOLOGIES, INC.
9003
In Commercial Distribution

  • 10810005340219 ()
  • 00810005340212 ()
9003

  • Electrosurgical return electrode, single-use
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.12
In Commercial Distribution

  • 04987669100042 ()


  • Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.13
In Commercial Distribution

  • 04987669101346 ()


  • Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.11US
In Commercial Distribution

  • 04987669100035 ()


  • Ophthalmic excimer laser system
NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.
NIDEK CO.,LTD.
EC-5000
In Commercial Distribution

  • 04987669100028 ()


  • Ophthalmic excimer laser system
NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.
NIDEK CO.,LTD.
EC-5000
In Commercial Distribution

  • 04987669100011 ()


  • Ophthalmic excimer laser system
ASSY, EXCIMER LASER SYSTEM,STAR S4 IR,
JOHNSON & JOHNSON SURGICAL VISION, INC.
0030-4864
In Commercial Distribution

  • 05050474573413 ()
0030-4864

  • Ophthalmic excimer laser system
WAVELIGHT EX500 EX LASER US
Alcon Laboratories, Inc.
8065990794
In Commercial Distribution

  • 00380659907944 ()

  • Weight: 1200 Pound
8065990794

  • Ophthalmic excimer laser system
No Description
Technolas Perfect Vision GmbH
Model2
In Commercial Distribution

  • 04050555004202 ()


  • Ophthalmic excimer laser system
The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D - naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D.
Carl Zeiss Meditec AG
MEL 80
In Commercial Distribution

  • 04049471000221 ()

  • Weight: 260 Kilogram
  • LxWxH: 1.55m x 0.80m x1.49m


  • Ophthalmic excimer laser system
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