Skip to content

DuraLazeTM HoLEP Laser Fiber

by Medkey, LLC

510(k) K153124

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153124 Date26 Jul 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DuraLaze HoLEP Laser Fiber is a Powered Laser Surgical Instrument designed for holmium:yttrium-aluminum-garnet (Ho:YAG) laser systems. It is intended for tissue ablation and fragmentation during surgical procedures, particularly in urological applications such as holmium laser enucleation of the prostate (HoLEP).

Supplied ETO sterilized and intended for single-use only, the fiber connects via a standard SMA-905 connector to compatible Ho:YAG laser systems. Regulated under FDA 510(k) clearance (K153124), it falls under the Powered Laser Surgical Instrument classification (GEX) and was determined substantially equivalent to predicate devices in 2016. Storage and handling must comply with sterile single-use protocols.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the DuraLaze™ HoLEP Laser Fiber specifically designed for?

    The DuraLaze™ HoLEP Laser Fiber is designed for holmium laser enucleation of the prostate (HoLEP), a urological procedure where tissue ablation and fragmentation are required. It connects to Ho:YAG laser systems to safely remove prostate tissue, making it ideal for minimally invasive urological surgeries.

  • Is the DuraLaze™ HoLEP Laser Fiber reusable, or is it meant for single-use only?

    The fiber is intended for single-use only and is supplied ETO-sterilized, ensuring sterile conditions for each procedure. Reuse is not recommended to maintain safety and efficacy.

  • How do I connect the DuraLaze™ HoLEP Laser Fiber to a Ho:YAG laser system?

    The fiber connects via a standard SMA-905 connector, which is compatible with most Ho:YAG laser systems. Ensure the connector is securely attached before use to maintain proper laser delivery.

  • What storage and handling precautions should I follow for the DuraLaze™ HoLEP Laser Fiber?

    Since it is a sterile, single-use device, storage must follow standard sterile single-use protocols. Keep it in its original packaging until ready for use, and avoid exposure to moisture or contamination to preserve sterility.

  • What regulatory pathway does the DuraLaze™ HoLEP Laser Fiber follow, and when was it cleared?

    The fiber was cleared via the FDA 510(k) process under K153124, determined substantially equivalent to predicate devices in 2016. It falls under the Powered Laser Surgical Instrument (GEX) classification and was reviewed by the Urology Devices Panel (SU).