510(k) · Cleared
ClearedComfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug, Comfortear Lacrisolve Punctum Plug,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Bioteck, Inc. · LZU Plug, Punctum
Cleared on Jun 20, 2014 as substantially equivalent to K030300 (Lacrimedics, Inc., 2003) and 1 other predicate after a 91-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Jun 20, 2014
- Review
- 91 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890919 (1989). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
- This deviceK140711 Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable…Paragon Bioteck, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK150288 PDO Absorbable Punctum PlugRiverpoint Medical · 2015
- Descendant · 2 generations on · 2 of its ownK162361 Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK241229 Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK213988 SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K150288PDO Absorbable Punctum PlugRiverpoint Medical · 2015 · cites it directly3descendants
- K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017 · 2 generations on2descendants
- K241229Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024 · 3 generations on0descendants
- K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890919 | Temporary Intracanalicular Collagen Implant | Eagle Vision, Inc. | 1989 | — |
| 0 (this device) | K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum… | Paragon Bioteck, Inc. | 2014 | — |
| +1 | K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015 | — |
| +2 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017 | — |
| +3 | K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024 | — |
| +3 | K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | Oasis Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
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 K241229 Hello,eyes® BIO Plugscore 8.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030300 | Opaque Herrick Lacrimal PlugSummary page 2…able Punctun Plugs have similar technological characteristics as the predicate devices. Like the currently marketed Opaque Herrick Lacrimal Plug (K030300), and the Temporary Intracanalicular Collagen Implant (K890919) the modified device is a sterile, monofilatment synth… | 2003 |
| * | K890919 | Temporary Intracanalicular Collagen ImplantSummary page 2…s the predicate devices. Like the currently marketed Opaque Herrick Lacrimal Plug (K030300), and the Temporary Intracanalicular Collagen Implant (K890919) the modified device is a sterile, monofilatment synthetic absorbable suture material at the same or similar diameter… | 1989 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150288 | PDO Absorbable Punctum Plug | 2015 | 3 |
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?
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZU
148in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZU
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZU
3in 2025
MAUDE reports naming product code LZU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 10 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 3 | 148 | 0 | 10 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
* Determine the potential effectiveness of a permanent occlusion,
* Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
* Temporarily enhance the efficacy of topical medications or ocular lubricants,
* Temporarily treat contact lens intolerance secondary to dry eye, and
* Temporarily treat dry eye after ocular surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140711: Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug, Comfortear Lacrisolve Punctum Plug,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140711
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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