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510(k) Data Aggregation
K Number
K202828Device Name
Surgical Green Laser System
Manufacturer
Realton (Suzhou) Medical Technology Co., Ltd.
Date Cleared
2021-06-04
(253 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K202702Device 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
878.4810Why 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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K Number
K202601Device Name
Single-use Sterile medical laser fiber
Manufacturer
Realton (Suzhou) Medical Technology Co., Ltd
Date Cleared
2020-12-15
(98 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Realton (Suzhou) Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous 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 prostatic hyperplasia (BPH).
Device Description
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.
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