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510(k) Data Aggregation

    K Number
    K211979
    Device Name
    Lumenis Y&R Laser System
    Manufacturer
    Lumenis Inc.
    Date Cleared
    2022-06-21

    (361 days)

    Product Code
    GEX, ONG
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lumenis Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows: 1410 nm Indications for Use: - Fractional skin resurfacing procedures 1927 nm Indications for Use - Fractional skin resurfacing procedures LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously - Fractional skin resurfacing procedures
    Device Description
    The Lumenis YandR Laser System consists of: - System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts) - Operator control panel with touch-screen technology (GUI) - NAFR handpiece and single-use removable tips - Footswitch and other laser safety accessories The non-ablative fractional NAFR handpiece emits two wavelengths - 1410nm and 1927nm. The 1410nm and 1927nm laser diode modules are located in the console and are coupled into the single handpiece via fiber optics. Through the GUI screen on the system console, the user can select either fractional wavelength, or a combination of both.
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    K Number
    K111213
    Device Name
    VISION ONE LASER SYSTEM
    Manufacturer
    LUMENIS INC.
    Date Cleared
    2011-07-25

    (84 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMENIS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including: - . Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative diabetic retinopathy . - Choroidal neovascularization . - Branch retinal vein occlusion . - . Retinal tears and detachments - Retinopathy of prematurity . - Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma
    Device Description
    The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser). The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used. The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.
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