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510(k) Data Aggregation

    K Number
    K152688
    Device Name
    LightLas Multi-Wavelength Medical Laser System
    Date Cleared
    2016-06-15

    (271 days)

    Product Code
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIGHTMED CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for: - · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe - · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe - · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp - Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet - age-related macular degeneration (wet AMD)- with Slitlamp - · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp
    Device Description
    LightLas 532/810 Multi-Wavelength Medical Laser System can emit 532 nm wavelength laser beam and 810 nm wavelength laser beam. The 532 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 810 nm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software. LightLas 532/810 Multi-Wavelength Medical Laser System is intended for use by ophthalmologists for treatment of ocular pathology, and the system consists of the following functional components: - LCD touch panel ● - Laser Console - Ophthalmic Instrument table ● - CSO Slitlamp SL980 (K992836) ● - Endolaser probe (K133019)
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