Home / 510(k) Clearances / K161457

510(k) K161457

XEN Glaucoma Treatment System by Allergan, Inc. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2016
Date Received
May 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type

Other clearances by Allergan, Inc.

  • K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants (June 2, 2021)
  • K193589 — TrueTear Intranasal Tear Neurostimulator (August 31, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)
  • K143354 — Natrelle 133 Plus Tissue Expander (August 20, 2015)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)
  • K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS (July 9, 2009)
  • K051852 — SINGLE AMPLIFIER FOR BOTOX (September 14, 2005)

Other clearances for product code KYF

  • K230975 — Ahmed® Glaucoma Valve Model FP7 (May 12, 2023)
  • K231051 — Ahmed® Glaucoma Valve Model FP8 (May 12, 2023)
  • K220032 — iStent infinite Trabecular Micro-Bypass System, Model iS3 (August 2, 2022)
  • K182518 — AHMED ClearPath Glaucoma Drainage Device (January 18, 2019)
  • K171451 — Ahmed Glaucoma Valve Model FP8 (August 8, 2017)
  • K162060 — Ahmed Glaucoma Valve (October 24, 2016)
  • K152996 — Molteno3 Glaucoma Implant (December 17, 2015)
  • K062252 — MOLTENO3 (September 27, 2006)
  • K060644 — AHMED GLAUCOMA VALVE, MODEL M4 (September 18, 2006)
  • K030350 — EXPRESS MINI GLAUCOMA SHUNT (March 13, 2003)