Home / 510(k) Clearances / K905427

510(k) K905427

EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG by Eagle Vision, Inc. — Product Code LZU

K905427 is an FDA 510(k) premarket notification submitted by Eagle Vision, Inc. for the device "EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG". The FDA issued a decision of Substantially Equivalent on June 6, 1991. The device falls under product code LZU (Plug, Punctum), a Class U device. Eagle Vision, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
December 4, 1990
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 Eagle Vision, Inc.

  • K053333 — EAGLEVISION GELLANSERTS, MODEL REF 0040 (May 2, 2006)
  • K030353 — MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS (April 25, 2003)
  • K991130 — FLEXPLUG (April 20, 1999)
  • K890919 — TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (May 16, 1989)
  • K890920 — EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE (April 11, 1989)
  • K883233 — EV MONOCANALICULAR STENT (TM) (August 22, 1988)

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