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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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KIT, PASCAL LIO, YELLOW, PASCAL STREAMLINE B RELEASE (577)
TOPCON MEDICAL LASER SYSTEMS, INC.
LIO for Streamline 577
In Commercial Distribution

  • 00855005006119 ()
SA-06162

  • Indirect binocular laser ophthalmoscope
KIT, PASCAL LIO, GREEN, PASCAL STREAMLINE B RELEASE (532)
TOPCON MEDICAL LASER SYSTEMS, INC.
LIO for Streamline 532
In Commercial Distribution

  • 00855005006102 ()
SA-06161

  • Indirect binocular laser ophthalmoscope
PASCAL Synthesis SLC & ESF (577 nm) for BQ B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 577
In Commercial Distribution

  • 00855005006096 ()
SA-06196

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 532
In Commercial Distribution

  • 00855005006089 ()
SA-06194

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis SLC & ESF (577 nm) for BM B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 577
In Commercial Distribution

  • 00855005006072 ()
SA-06197

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis SLC & ESF (532 nm) for BM C RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 532
In Commercial Distribution

  • 00855005006065 ()
SA-06195

  • Ophthalmic solid-state laser system, photodisruption
Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher B
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 577
In Commercial Distribution

  • 00855005006058 ()
SA-06377

  • Ophthalmic solid-state laser system, photodisruption
Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 532
In Commercial Distribution

  • 00855005006041 ()
SA-06376

  • Ophthalmic solid-state laser system, photodisruption
(577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577
In Commercial Distribution

  • 00855005006034 ()
SA-06285

  • Ophthalmic solid-state laser system, photodisruption
(532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006027 ()
SA-06284

  • Ophthalmic solid-state laser system, photodisruption
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