Lacrimedics, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Lacrimedics, Inc.” (first 1985, latest 2016), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 148 |
| 2015 | 0 | — |
| 2016 | 1 | 155 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZU | Plug, Punctum | 10 | 10 |
| HLJ | Ophthalmoscope, Battery-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (11)
Most recent Lacrimedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161673 | LacriPro Punctum Plug | LZU | 2016-11-18 | 155 |
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | LZU | 2014-06-03 | 148 |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | LZU | 2003-05-09 | 100 |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB | LZU | 2002-07-01 | 27 |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | LZU | 2000-06-19 | 12 |
| K963708 | HERRICK ULTIMATE PUNCTUM PLUG | LZU | 1997-04-14 | 210 |
| K963501 | HERRICK ULTIMATE PUNCTUM PLUG | LZU | 1997-04-14 | 223 |
| K944402 | FOCOMETER | HLJ | 1994-11-22 | 71 |
| K896175 | HERRICK LACRIMAL PLUG TM. | LZU | 1990-01-22 | 89 |
| K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST | LZU | 1989-11-02 | 63 |
2 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2022-01-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lacrimedics, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Lacrimedics, Inc.” (first 1985, latest 2016), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lacrimedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lacrimedics, Inc. is 92 days.
Which FDA product codes appear under Lacrimedics, Inc.?
The most frequent FDA product codes under this applicant name are LZU (Plug, Punctum, 10); HLJ (Ophthalmoscope, Battery-Powered, 1).
Next steps
- See all 12 Lacrimedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZU, Lacrimedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.