510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K161457Substantially Equivalent

XEN Glaucoma Treatment System

Allergan, Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161457 is the FDA 510(k) clearance record for XEN Glaucoma Treatment System, a class II device, cleared for Allergan, Inc. on under FDA product code KYF (Implant, Eye Valve). FDA records list 39 510(k) clearances for Allergan, Inc., from to . As of , FDA records show one recall naming K161457.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KYF Implant, Eye Valve
Regulation
21 CFR 886.3920
Device class
Class II
Review panel
Ophthalmic
Applicant
Allergan, Inc. 26970 Aliso Viejo Pkwy., Suite 200, Aliso Viejo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYF

Trailing 12 months

FDA records hold no clearances under product code KYF in the trailing twelve months.

FDA records show no clearances under product code KYF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260