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510(k) Data Aggregation

    K Number
    K161925
    Date Cleared
    2016-10-05

    (84 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    CO2 Laser Therapy Machine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CO2 Laser Therapy Machine is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

    The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

    Device Description

    The CO2 Laser Therapy Machine is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.

    The proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment.

    The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance.

    The proposed device includes the following components: Surgery tip, Surgery tip Arm, Touchscreen, Emergency Switch, Key Switch, Goggles for Patient, Goggles for Doctor, Foot Switch.

    AI/ML Overview

    The provided document is a 510(k) Summary for a CO2 Laser Therapy Machine. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document presents a comparison of the proposed device against a predicate device across various parameters. It doesn't explicitly state "acceptance criteria" for each parameter with numeric thresholds, but rather lists characteristics that are considered "Substantially Equivalent (SE)" if they match or are comparable to the predicate. The performance is reported as the proposed device's specifications.

    ParameterAcceptance Criteria (Implied by Predicate)Reported Device PerformanceRemark (as per document)
    Product CodeGEXGEXSE
    Regulation No.21 CFR 878.481021 CFR 878.4810SE
    Class22SE
    Where usedHospitalHospitalSE
    Intended UseHuman tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.SE
    Maximum PowerCFL-10: 12W (±20%), UFL-60: 30W (±20%)30WSE
    Work ModeScanner (half, fast and random), Surgery (CW, repeat and pulse)Surgery (Single Pulse, Continuous, Muti-Pulse)SE
    Wavelength10.6 um10.6 umSE
    Mode StructureTEM00TEM00SE
    Beam Delivery7 knucklearmkey joints light arm7 knucklearmkey joints light armSE
    Light ArmCFL-10: 0.97m, UFL-60: 1.17m1.32mAnalysis
    Aiming Beam650nm red diode laser (
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