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510(k) Data Aggregation
K Number
K153124Device Name
DuraLazeTM HoLEP Laser Fiber
Manufacturer
Date Cleared
2016-07-26
(271 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MedKey, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.
Device Description
The DuraLaze™ HoLEP Laser Fiber is a straight fire fiber optic laser energy delivery device. The laser fiber contains a 550µm silica core jacketed with ethylene tetrafluoroethylene (ETFE) and a standard SMA-905 laser connector with a strain relief. The distal 10 cm of the ETFE jacket is pre-stripped and coated during the manufacture of the laser fiber to minimize the potential of laser fiber damage caused by jacket stripping during surgical use and for the convenience of the operating room staff. The pre-stripped distal tip comes with a printed axial line that improves the surgeon's visibility by increasing the contrast between the fiber tip and the surrounding tissue. The DuraLaze™ HoLEP Laser Fiber is contained within a 9 French, polyurethane stability sheath that holds and secures the laser fiber during surgical use. The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.
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