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510(k) K964774

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS by Fci Ophthalmics, Inc. — Product Code LZU

K964774 is an FDA 510(k) premarket notification submitted by Fci Ophthalmics, Inc. for the device "PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code LZU (Plug, Punctum), a Class U device. Fci Ophthalmics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
October 22, 1996
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 Fci Ophthalmics, Inc.

  • K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (August 7, 2006)
  • K061398 — SNUG PLUG PUNCTUM PLUG (July 11, 2006)
  • K041869 — SELF RETAINING BICANALICULUS INTUBATION SET (November 18, 2004)
  • K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (September 17, 2003)
  • K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (August 22, 2003)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K992294 — BIOCERAMIC ORBITAL IMPLANT (April 19, 2000)
  • K991238 — FCI CRAWFORD PROBE INTUBATION SETS (July 8, 1999)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)

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)
  • 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)

FDA data resources