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510(k) K991130

FLEXPLUG by Eagle Vision, Inc. — Product Code LZU

K991130 is an FDA 510(k) premarket notification submitted by Eagle Vision, Inc. for the device "FLEXPLUG". The FDA issued a decision of Substantially Equivalent on April 20, 1999. 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
April 20, 1999
Date Received
April 2, 1999
Clearance Type
Special
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)
  • K905427 — EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG (June 6, 1991)
  • 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