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510(k) K222164

Visant Medical Canalicular Plug by Visant Medical, Inc. — Product Code LZU

K222164 is an FDA 510(k) premarket notification submitted by Visant Medical, Inc. for the device "Visant Medical Canalicular Plug". The FDA issued a decision of Substantially Equivalent on December 23, 2022. The device falls under product code LZU (Plug, Punctum), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2022
Date Received
July 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

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  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • K190210 — Tear Pool Dissolvable Punctum Plugs (October 24, 2019)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K150288 — PDO Absorbable Punctum Plug (August 28, 2015)
  • K140352 — VERAPLUG (November 13, 2014)
  • K140711 — COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLU (June 20, 2014)
  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)
  • K090938 — FLOW CONTROLLER (June 4, 2009)

FDA data resources