Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K132042
    Device Name
    AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
    Manufacturer
    X6D, LTD.
    Date Cleared
    2014-04-28

    (300 days)

    Product Code
    HOY
    Regulation Number
    886.4750
    Why did this record match?
    Product Code :

    HOY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amblyz™ System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
    Device Description
    The Amblyz™ device is an optical eyewear using a Liquid Crystal lens and electronics technology that acts as an intermittent shutter. The shutter incorporated in the optical lens performs an occlusion of the sound eye in an intermittent mode by changing the lens from a clear to an opaque state via electronic control. The system incorporates the following components: Spectacle Frame, Liquid Crystal Shutter (LCS), Earpieces, Nose Piece, Clip to Hold Refractive Lens, Micro-USB Connector, LED Indicator, ON/OFF Switch, Programming Button, Amblyz™ onboard Software, Amblyz™ Technician Software.
    Ask a Question
    K Number
    K050856
    Device Name
    LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
    Manufacturer
    OPHTHOCARE LTD.
    Date Cleared
    2005-05-31

    (56 days)

    Product Code
    HOY, HQG, HQY, HQZ
    Regulation Number
    886.4750
    Why did this record match?
    Product Code :

    HOY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
    Device Description
    The LCG System comprises the following main components: The Spectacles Unit (LCGU) comprised of the refractive optical lens, Liquid Crystal Module (LCM) and the electronic control that resides in the holding strap. The adjustable holding strap contains an electronic controller with an activation button (Tact Switch) and small rechargeable batteries that provide the electric power. The Reporting and Compliance Box (RCB) is a bedside device that serves as a charger of the spectacle's batteries. In addition, it provides a means to monitor the compliance of the patient, while providing a feedback to the user, as it records the actual wear-time of the glasses, comparing it to the prescribed time. Technician/Factory Setup Software (LCG Set) is software residing on a PC at the factory and is used for setting the LCGU performance parameters. During setup, the LCGU is connected to the PC via the RCB by means of RS232 link.
    Ask a Question
    K Number
    K971465
    Device Name
    NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
    Manufacturer
    NATIONAL HEALTHCARE MFG. CORP.
    Date Cleared
    1997-06-04

    (43 days)

    Product Code
    HOY, HMX, HNM, HQR, KKX
    Regulation Number
    886.4750
    Why did this record match?
    Product Code :

    HOY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These kits are a convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures. National Corporation does not cause or promote new intended uses for the devices within these kits.
    Device Description
    The National Healthcare Manufacturing custom ophthalmic procedure trays or kits are sterile, disposable, medical device convenience kits. These kits are custom to the customer, whose specifications determine the devices included in the kit.
    Ask a Question

    Page 1 of 1