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510(k) Data Aggregation

    K Number
    K964074
    Device Name
    DIOLITE 532
    Manufacturer
    IRIDERM DIV.
    Date Cleared
    1997-04-01

    (172 days)

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

    IRIDERM DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DioLite™ 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.
    Device Description
    The DioLite 532 is a semiconductor-based dermatology laser system which delivers 532 nm laser light. The system delivers up to 3 Watts of power, in pulses of 1 to 100 milliseconds duration, at repetition rates up to 15 Hz, into treatment spots of 200 to 1400 microns diameter.
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    K Number
    K960971
    Device Name
    OCULIGHT GL
    Manufacturer
    IRIDERM DIV.
    Date Cleared
    1996-08-28

    (170 days)

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

    IRIDERM DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.
    Device Description
    The OcuLight GL is a semiconductor-based ophthalmic laser photocoagulator which delivers true continuous wave green laser light. It will only be used in conjunction with three fiber optically coupled delivery devices which have received prior FDA-premarket clearance: the IRIS Slit Lamp Adapter (K912918 for retinal photocoagulation and K913430 for laser trabeculoplasty), the IRIS EndoProbe (K894841), and the IRIS Laser Indirect Ophthalmoscope (K903288).
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    K Number
    K960522
    Device Name
    DIOPEXY PROBE
    Manufacturer
    IRIDERM DIV.
    Date Cleared
    1996-07-19

    (164 days)

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

    IRIDERM DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is transscleral retinal photocoagulation (TSRPC) for retinopexy.
    Device Description
    The IRIS DioPexy Probe is a multiple-use fiber optic laser delivery device with integral optics, which terminates with a contact prism tip. It must be directly connected to a compatible IRIS OcuLight SL or SLx (810 nm-infrared) Photocoagulator. The prism tip is designed to deflect laser energy 90° from the axis of the shaft and be simultaneously act as a scleral depressor. The fiber optic cable is 3 meters (10 feet). The DioPexy Probe is shipped from the factory non-sterile in a hard plastic container. The device can be sterilized between each use in this container using Ethylene Oxide (EtO) gas in accordance with the user instructions.
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