SolarGen 2100s Holmium:YAG Laser Console


Product Overview

SolarGen 2100s Holmium:YAG Laser Console
CardioGenesis - NS2000


Device Description

A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod [typically yttrium-aluminium-garnet doped with holmium (Ho:YAG)] to emit a high-power laser beam intended for transmyocardial revascularization surgical procedures (open surgical approach); it does not include frequency-doubling technology. It includes a light source, controls/foot-switch and may include the handpiece/guide. It emits a midinfrared wavelength, and may be used with a handpiece capable of injecting agents/materials into the heart (e.g., stem cells).


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • 10.00
  • Special Storage Condition, Specify
    • It is recommended that the laser console be covered when stored and never stored in an area at or below freezing temperature (≤0°C or ≤32°F)
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 14.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MNO

    Device Name: System, Laser, Transmyocardial Revascularization

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00877234000096

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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