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510(k) Data Aggregation

    K Number
    K032191
    Device Name
    OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
    Manufacturer
    LUXSANO AB
    Date Cleared
    2003-08-20

    (34 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K013365,K022569,K022568,K023081
    Why did this record match?
    Device Name :

    OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM

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

    The OmniLight FPL System is intended to be used in the following procedures:

    1. Hair Removal in all Skin types according to the Fitzpatrick Scale
    2. Permanent Hair reduction
    3. Treatment of Vascular Lesions
    4. Treatment of Pigmented Lesion
    5. Tattoo Removal
    Device Description

    The OmniLight Fluorescent Pulsed Light System delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

    AI/ML Overview

    The OmniLight Fluorescent Pulsed Light System did not include performance data or studies to support its substantial equivalence beyond its comparison to predicate devices. The 510(k) Summary explicitly states "Performance Data: None".

    Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because no such study or data was provided in the submission. The FDA cleared this device based on its substantial equivalence to previously cleared predicate devices (ProLite and Plasmalite MPX Pulsed Light System) without requiring new performance data.

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