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510(k) K190210

Tear Pool Dissolvable Punctum Plugs by Alphamed, Inc. — Product Code LZU

K190210 is an FDA 510(k) premarket notification submitted by Alphamed, Inc. for the device "Tear Pool Dissolvable Punctum Plugs". The FDA issued a decision of Substantially Equivalent on October 24, 2019. The device falls under product code LZU (Plug, Punctum), a Class U device. Alphamed, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2019
Date Received
February 4, 2019
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

Other clearances by Alphamed, Inc.

  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K990321 — ALPHAMED GEMINI SENSOR, SNORING SENSOR (June 1, 1999)
  • K926446 — EZ PUMP (September 27, 1993)

Other clearances for product code LZU

  • K241229 — Hello,eyes® BIO Plug (June 28, 2024)
  • K222164 — Visant Medical Canalicular Plug (December 23, 2022)
  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • 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