Cleared Traditional

XEN Glaucoma Treatment System (K161457) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161457 · Allergan, Inc. · Ophthalmic device
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Nov 2016
Decision
179d
Days
Class 2
Risk

K161457 is an FDA 510(k) clearance for the XEN Glaucoma Treatment System. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Allergan, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 21, 2016 after a review of 179 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Allergan, Inc. devices

Submission Details

510(k) Number K161457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2016
Decision Date November 21, 2016
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - KYF Implant, Eye Valve

All 24
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K161457.
Ahmed® Glaucoma Valve Model FP7
K230975 · New World Medical, Inc. · May 2023
Ahmed® Glaucoma Valve Model FP8
K231051 · New World Medical, Inc. · May 2023
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · Glaukos Corporation · Aug 2022
AHMED ClearPath Glaucoma Drainage Device
K182518 · New World Medical, Inc. · Jan 2019