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510(k) Data Aggregation

    K Number
    K990452
    Device Name
    ORLIGHT 2000 SURGICAL LASER SYSTEM
    Manufacturer
    YBEAM TECHNOLOGIES, INC.
    Date Cleared
    1999-04-29

    (76 days)

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

    YBEAM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrLight 2000 CO2 Surgical Laser System is intended for use in the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing. The specific indications are as follows: - Ablation, vaporization, excision, incision, and coagulation of soft tissue in laser skin resurfacing, laser derm-abrasion, and laser burn debridement. - Laser skin resurfacing (ablation and/or vaporization) for the treatment of wrinkles, rhytids, and furrows. - Laser skin resurfacing (ablation, vaporization, excision, incision, and coagulation) for the reduction, removal and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas, tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts). - Laser incision and/or excision of soft tissue for the performance of laser blepharoplasty.
    Device Description
    The OrLight 2000 Surgical Laser system is a carbon dioxide laser that utilizes a radio frequency amplifier. Laser treatment is delivered to the target tissue through an articulated arm or a hollow wave guide.
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