Manufacturer
Medkey, LLCDuraLazeTM HoLEP Laser Fiber
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K153124
- Device name
- DuraLazeTM HoLEP Laser Fiber
- Company
- Medkey, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-10-29
- Decision date
- 2016-07-26
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for 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.
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.
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.
Summary parsed at:2026-06-01 06:05:25 UTC
