Single-use Sterile medical laser fiber

The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo‐selective vaporization of the prostate for benign prostatic hyperplasia (BPH). The fiber is contraindicated in the presence of severe urethral strictures; however, the system can be used in the treatment of urethral strictures with proper cautions. A severe stricture is any stricture with visible narrowing via urethrography or ultrasonography, with near total obstruction that make passage of instruments difficult or dangerous.

The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostate for benign prostatic hyperplasia (BPH).

The single-use sterile medical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. The optical fiber material is fused quartz, and its core diameter is 760 μm. One end of the optical fiber is a special connector, which can be connected to the medical laser surgery system. The output structure of the other end of the optical fiber can be divided into side-firing type and front-firing type: W760SF-30, B760SF-30, G760SF-30 and P760SF-30 are side-firing types, W760F-30, B760FF-30, G760FF-30 and P760FF-30 are front-firing types. The product is sterilized by EO. It is a disposable medical device.