510(k) · Cleared
ClearedHello,eyes® BIO Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Optics Co., Ltd. · LZU Plug, Punctum
Cleared on Jun 28, 2024 as substantially equivalent to K162361 (Oasis Medical, Inc., 2017) after a 57-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jun 28, 2024
- Review
- 57 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890919 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
- 3 generations backK140711 Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable…Paragon Bioteck, Inc. · 2014
- 2 generations backK150288 PDO Absorbable Punctum PlugRiverpoint Medical · 2015
- 1 generation backK162361 Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
- This deviceK241229 Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890919 | Temporary Intracanalicular Collagen Implant | Eagle Vision, Inc. | 1989 | — |
| −3 | K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum… | Paragon Bioteck, Inc. | 2014 | — |
| −2 | K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015 | — |
| −1 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017 | — |
| 0 (this device) | K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 K222164 Visant Medical Canalicular Plugscore 4.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K162361 | Soft Plug Extended Duration 180 Canalicular PlugSummary page 4…vice Class: Unclassified Panel: Ophthalmic Product Code: LZU 4. Predicate Device The subject device is substantially equivalent to the following predicate devices : K162361, SOFT PLUG® Extended Duration 180 Canalicular Plug by OASIS Medical, Inc. 5. Device Description Intracanalicular Plug named Hell… | 2017 |
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 35 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K162361.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Hello,eyes@ BIO Plug is intended to temporarily block tear drainage by the occlusion of the
canaliculus in order to
- 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,
- Temporarily treat dry eye after ocular surgery, and,
- Determine the potential effectiveness of permanent occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241229: Hello,eyes® BIO Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241229
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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