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510(k) Data Aggregation

    K Number
    K202828
    Device Name
    Surgical Green Laser System
    Manufacturer
    Realton (Suzhou) Medical Technology Co., Ltd.
    Date Cleared
    2021-06-04

    (253 days)

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

    Realton (Suzhou) Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).
    Device Description
    The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601. The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns. The surgical green laser system consists of a semiconductor-pumped controller, Laser internal circulating cooling system, electronic control system and footswitch.
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    K Number
    K202702
    Device Name
    FLARE Single-Use Surgical Laser Fiber
    Manufacturer
    Realton (Suzhou) Medical Technology Co., Ltd.
    Date Cleared
    2021-02-26

    (163 days)

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

    Realton (Suzhou) Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm-2140 mm and equipped with SMA 905 compatible connector. FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.
    Device Description
    FLARE™ single-use surgical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The optical fiber material is fused quartz. One end of the fiber is connected to the medical laser equipment through a connector, and the other end directly outputs laser energy for laser operation. The product is sterilized by EO. It is a disposable medical device.
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