# K153124: DuraLazeTM HoLEP Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Medkey, LLC
- Decided: Jul 26, 2016 after 271 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936109 (1994). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 4.
- K093691: Accumax, Boston Scientific Corp (2009) Summary page 4.

## Indications for use
The DuralLaze™ 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.

Source page: https://510kreport.com/device/K153124
Methodology: https://510kreport.com/methodology