XEN Glaucoma Treatment System— 510(k) K161457
Substantially EquivalentAllergan, Inc.
FDA 510(k) clearance K161457 for XEN Glaucoma Treatment System, Substantially Equivalent on 2016-11-21. Applicant: Allergan, Inc.. Device class: 2.
Clearance details
- Applicant
- Allergan, Inc.
- Product code
- Code KYF
- Device class
- Class 2
- Regulation
- 21 CFR 886.3920
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Recent devices under product code KYF
view allMore clearances from Allergan, Inc.
view allAdverse events under product code KYF
product code KYF- Injury
- 1,543
- Malfunction
- 646
- Total
- 2,189
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161457
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161457.
Data sourced from openFDA. This site is unofficial and independent of the FDA.