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510(k) K140026

COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST by Lacrimedics, Inc. — Product Code LZU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2014
Date Received
January 6, 2014
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 Lacrimedics, Inc.

  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K030300 — OPAQUE HERRICK LACRIMAL PLUG (May 9, 2003)
  • K021831 — OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-O (July 1, 2002)
  • K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (June 19, 2000)
  • K963501 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K963708 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K944402 — FOCOMETER (November 22, 1994)
  • K896175 — HERRICK LACRIMAL PLUG TM. (January 22, 1990)
  • K895342 — COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (November 2, 1989)
  • K890714 — LACRIMAL EFFICIENCY TEST (TM) (May 17, 1989)

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  • 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)
  • K090938 — FLOW CONTROLLER (June 4, 2009)