Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DuraLazeTM HoLEP Laser Fiber

K-Number: K153124 · 2016-07-26

ApplicantMedkey, LLC
Decision Date2016-07-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DuraLazeTM HoLEP Laser Fiber is a medical device manufactured by Medkey, LLC. It received FDA 510(k) clearance on 2016-07-26 under approval number K153124. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuraLazeTM HoLEP Laser Fiber?

DuraLazeTM HoLEP Laser Fiber is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Medkey, LLC. The 510(k) number is K153124.

When was DuraLazeTM HoLEP Laser Fiber approved by the FDA?

DuraLazeTM HoLEP Laser Fiber received FDA 510(k) clearance on 2016-07-26, under approval number K153124.

What company makes DuraLazeTM HoLEP Laser Fiber?

DuraLazeTM HoLEP Laser Fiber is manufactured by Medkey, LLC.

What is the FDA product code for DuraLazeTM HoLEP Laser Fiber?

The FDA product code for DuraLazeTM HoLEP Laser Fiber is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT07580404 Emsella for Reducing tSUI After HOLEP NOT_YET_RECRUITING NCT07087977 HoYAG vs TFL in miniPCNL With ClearPetra RECRUITING NCT06649357 Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate RECRUITING NCT05155891 Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate ACTIVE_NOT_RECRUITING

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑