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510(k) K161673

LacriPro Punctum Plug by Lacrimedics, Inc. — Product Code LZU

K161673 is an FDA 510(k) premarket notification submitted by Lacrimedics, Inc. for the device "LacriPro Punctum Plug". The FDA issued a decision of Substantially Equivalent on November 18, 2016. The device falls under product code LZU (Plug, Punctum), a Class U device. Lacrimedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2016
Date Received
June 16, 2016
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.

  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)
  • 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)

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)
  • K190210 — Tear Pool Dissolvable Punctum Plugs (October 24, 2019)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • 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