FX Series Energy Platform


Product Overview

FX Series Energy Platform
Valleylab FX8 - VLFX8GENZD


Device Description

An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - millibar
    • 1060.00
    • 700.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 15.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 104.00
    • 50.00
  • Special Storage Condition, Specify
    • The system can be stored for up to 1 year without performance degradation upon use.
  • Storage Environment Atmospheric Pressure - millibar
    • 1060.00
    • 500.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • 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: GEI

    Device Name: Electrosurgical, Cutting & Coagulation & Accessories

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: SU

    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: 878.4400

    Third Party Flag: Y

    Medical Specialty: SU


    Device Identifiers

    Device Id: 10884521780408

    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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