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)

XEN Glaucoma Treatment System

K-Number: K161457 · 2016-11-21

ApplicantAllergan, Inc.
Decision Date2016-11-21
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

XEN Glaucoma Treatment System is a medical device manufactured by Allergan, Inc.. It received FDA 510(k) clearance on 2016-11-21 under approval number K161457. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XEN Glaucoma Treatment System?

XEN Glaucoma Treatment System is a medical device that received FDA 510(k) clearance on 2016-11-21. It is manufactured by Allergan, Inc.. The 510(k) number is K161457.

When was XEN Glaucoma Treatment System approved by the FDA?

XEN Glaucoma Treatment System received FDA 510(k) clearance on 2016-11-21, under approval number K161457.

What company makes XEN Glaucoma Treatment System?

XEN Glaucoma Treatment System is manufactured by Allergan, Inc..

What is the FDA product code for XEN Glaucoma Treatment System?

The FDA product code for XEN Glaucoma Treatment System is KYF.

Related Clinical Trials

NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

Related PubMed Literature

PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Allergan, Inc.

K190674REFRESH RELIEVA For CONTACTS

Related Devices (Code: KYF)

K162060Ahmed Glaucoma ValveNew World Medical, Inc. K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.

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.

↑