510(k) Report

510(k) · Cleared

Cleared

Eaglevision Gellanserts, Model Ref 0040

K053333510(k) TraditionalCleared May 2, 2006152-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eagle Vision, Inc. · LZU Plug, Punctum

Cleared on May 2, 2006 as substantially equivalent to K850649 (Lacrimedics, Inc., 1985) and 8 other predicates after a 152-day review. Its family tree reaches back 2 generations to 1989.

Decided
May 2, 2006
Review
152 days
Class
Class U
Product code
LZU
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K890919 (1989). 11 ancestors in all, the oldest K850649 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 2 other ancestors1995: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor1985: 1 other ancestor2000: 1 other ancestorK890919 · Temporary Intracanalicular Collagen Implant · Eagle Vision, Inc. · 1989K013613 · Soft Plug Absorbable Plug-SA · Oasis Medical, Inc. · 2002 · recalled19851990199520002005
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 2 other ancestors K013613 · Soft Plug Absorbable Plug-SA · Oasis Medical, Inc. · 2002 · recalledK890919 · Temporary Intracanalicular Collagen Implant · Eagle Vision, Inc. · 19890
  1. Root · 2 generations backK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
  2. 1 generation backK013613 Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · Recalled
  3. This deviceK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K890919Temporary Intracanalicular Collagen ImplantEagle Vision, Inc.1989—
−1K013613Soft Plug Absorbable Plug-SAOasis Medical, Inc.20021
0 (this device)K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198910
199020
199510
200010
200220
200310
FIG. 1 — Lineage of K053333, 1989–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LZU device

  1. #1 K241229 Hello,eyes® BIO Plugscore 8.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K850649Absorbable Intracanalicular Collagen Implant
Summary page 1
…ICATION: Class 11per 21 CFR § 886 PRODUCT CODE 86 (LZU) PREDICATE EagleVision Gellanserts are substantially equivalent to: DEVICES: * K850649 ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT * K89091 9 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT…
Lacrimedics, Inc.1985—
*K890919Temporary Intracanalicular Collagen Implant
Summary page 1
…E EagleVision Gellanserts are substantially equivalent to: DEVICES: * K850649 ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT * K89091 9 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT * K895342 COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY…
Eagle Vision, Inc.1989—
*K895342Collagen Implants for the Lacrimal Efficiency Test
Summary page 1
…: * K850649 ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT * K89091 9 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT * K895342 COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST * K897190…
Lacrimedics, Inc.19891
*K897190Look Temporary Intracanalicular Collagen Implant
Summary page 1
…LAR COLLAGEN IMPLANT * K895342 COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST * K897190 LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT * K946357…
Look, Inc.1990—
*K946357Collagen Intracanalicular Plug
Summary page 1
…TEST * K897190 LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT * K946357 COLLAGEN INTRACANALICULAR PLUG * K013613 SOFT PLUG ABSORBABLE PLUG-SA * K…
Oasis Medical, Inc.1995—
*K013613Soft Plug Absorbable Plug-SA
Summary page 1
…PORARY INTRACANALICULAR COLLAGEN IMPLANT * K946357 COLLAGEN INTRACANALICULAR PLUG * K013613 SOFT PLUG ABSORBABLE PLUG-SA * K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG…
Oasis Medical, Inc.20021
*K020882Sharpoint Ultraplug Extended Wear Plug
Summary page 1
…IMPLANT * K946357 COLLAGEN INTRACANALICULAR PLUG * K013613 SOFT PLUG ABSORBABLE PLUG-SA * K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG • K022043 SMARTPLUG MODEL 500 * K0…
Surgical Specialties Corp2002—
*K022043Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503
Summary page 1
…G * K013613 SOFT PLUG ABSORBABLE PLUG-SA * K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG • K022043 SMARTPLUG MODEL 500 * K030300 OPAQUE HERRICK LACRIMAL PLUG…
Medennium, Inc.2002—
*K030300Opaque Herrick Lacrimal Plug
Summary page 1
…LE PLUG-SA * K020882 SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG • K022043 SMARTPLUG MODEL 500 * K030300 OPAQUE HERRICK LACRIMAL PLUG I…
Lacrimedics, Inc.2003—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 13.1 years on median.
  • 2 of the 11 ancestors have a recall of any class.

How does its category compare?

All LZU devices

LZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZU

1in 2024

2009: 12014: 32015: 12016: 12017: 12019: 12022: 22024: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZU

148in 2014

2014: 148 days median
2007high 148 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZU

2in 2022

2022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZU

3in 2025

2007: 102008: 122009: 112010: 52011: 62012: 72013: 172014: 102015: 12017: 32018: 22020: 22023: 52024: 12025: 3
2007high 17 (2013) · low 0 (2016)2025

MAUDE reports naming product code LZU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—010
20080—012
20091—011
20100—05
20110—06
20120—07
20130—017
20143148010
20151—01
20161—00
20171—03
20180—02
20191—00
20200—02
20210—00
20222—20
20230—05
20241—01
20250—03
20260—0—

What is it indicated for?

The EagleVision Gellansert Tm is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:

Determine the potential effectiveness of permanent occlusion,

Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,

Increase retention of ocular medications

Temporarily treat contact lens intolerance secondary to dry eye, and

Treat dry eye after surgery.

Indications for use as stated in the FDA summary.

More from Eagle Vision, Inc.

7 FDA decisions under this applicant name. See the company

  • K030353Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
  • K991130FlexplugEagle Vision, Inc. · 1999
  • K905427Eagle Vision Freeman Radiopague Punctum PlugEagle Vision, Inc. · 1991
  • K890919Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
  • K890920Eagle Vision-Freeman (TM) Punctal ValveEagle Vision, Inc. · 1989

Recent decisions in LZU

The LZU category page

  • K241229Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
  • K222164Visant Medical Canalicular PlugVisant Medical, Inc. · 2022
  • K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
  • K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc. · 2019
  • K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017

https://510kreport.com/device/K053333 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053333: Eaglevision Gellanserts, Model Ref 0040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053333

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026