Cleared Traditional

XEN Glaucoma Treatment System

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

About This 510(k) Submission

K161457 is an FDA 510(k) clearance for the XEN Glaucoma Treatment System, a Implant, Eye Valve (Class II — Special Controls, product code KYF), submitted by Allergan, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 21, 2016, 179 days after receiving the submission on May 26, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number K161457 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KYF — Implant, Eye Valve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3920

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