XEN Glaucoma Treatment System— 510(k) K161457

Substantially Equivalent

Allergan, Inc.

FDA 510(k) clearance K161457 for XEN Glaucoma Treatment System, Substantially Equivalent on 2016-11-21. Applicant: Allergan, Inc..

Clearance details

Applicant: Allergan, Inc.
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 2016-05-26
Decision date: 2016-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYF

product code KYF

Injury: 1,543
Malfunction: 646
Total: 2,189

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.