510(k) · Cleared
ClearedLacriPro Punctum Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lacrimedics, Inc. · LZU Plug, Punctum
Cleared on Nov 18, 2016 as substantially equivalent to K021936 (Moist Medical, Inc., 2002) after a 155-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 18, 2016
- Review
- 155 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021936 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021936 Moist Punctal Plug SystemMoist Medical, Inc. · 2002
- This deviceK161673 LacriPro Punctum PlugLacrimedics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021936 | Moist Punctal Plug System | Moist Medical, Inc. | 2002 | — |
| 0 (this device) | K161673 | LacriPro Punctum Plug | Lacrimedics, Inc. | 2016 | — |
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? (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 |
|---|---|---|---|
| * | K021936 | Moist Punctal Plug SystemSummary page 4…nctum Plug Product Code: LZU Predicate Device: AquaFlo Punctum Plugs Predicate Device 510(k) No.: K021936 Description of Device The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to b… | 2002 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
LacriPro plugs may be used to:
- Treat Dry Eye Syndrome
- Treat ocular dryness secondary to contact lens use
- Enhance the efficacy of topical ocular medications
- Prevent complications due to dry eyes after surgery
- Treat the Dry Eye component of ocular surface diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161673: LacriPro Punctum Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161673
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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