FDA product code LZU: Plug, Punctum
LZU is the FDA product code for plug, punctum. It is a Unclassified device, reviewed by the Ophthalmic panel. FDA has cleared 49 510(k) submissions under LZU, 3 in the last five years, from 23 different applicants. The average 510(k) review took 111 days (median 89); 57 days on average over the last three years. FDA has posted 4 recalls for LZU devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Plug, Punctum |
| Device class | Unclassified |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LZU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 237 |
| 2019 | 1 | 262 |
| 2022 | 2 | 160 |
| 2024 | 1 | 57 |
Compare with all 510(k) review times · Search every LZU clearance
Top LZU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lacrimedics, Inc. | 10 | 2016-11-18 |
| Oasis Medical, Inc. | 6 | 2022-06-03 |
| Eagle Vision, Inc. | 5 | 2006-05-02 |
| Odyssey Medical, Inc. | 3 | 2009-06-04 |
| Fci Ophthalmics, Inc. | 3 | 2006-07-11 |
18 more applicants have LZU clearances. See the full list in Caduvo.
Most recent LZU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241229 | Bio Optics Co., Ltd. | Hello,eyes® BIO Plug | 2024-06-28 | 57 |
| K222164 | Visant Medical, Inc. | Visant Medical Canalicular Plug | 2022-12-23 | 155 |
| K213988 | Oasis Medical, Inc. | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | 2022-06-03 | 165 |
| K190210 | Alphamed, Inc. | Tear Pool Dissolvable Punctum Plugs | 2019-10-24 | 262 |
| K162361 | Oasis Medical, Inc. | Soft Plug Extended Duration 180 Canalicular Plug | 2017-04-17 | 237 |
Recalls for LZU devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-01-17.
| Year | Recalls |
|---|---|
| 2022 | 2 |
Frequently asked questions
What is FDA product code LZU?
LZU is the FDA product code for plug, punctum. It is a Unclassified device, reviewed by the Ophthalmic panel.
What device class is LZU?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZU?
Across 49 cleared submissions the average was 111 days from receipt to decision (median 89).
Which companies have the most LZU clearances?
Lacrimedics, Inc. (10); Oasis Medical, Inc. (6); Eagle Vision, Inc. (5); Odyssey Medical, Inc. (3); Fci Ophthalmics, Inc. (3).
Have LZU devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2022-01-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LZU
- Run a recall and safety report across every LZU manufacturer
- Watch product code LZU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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