Lombart Lenses, Ltd.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Lombart Lenses, Ltd.” (first 1994, latest 1997), plus 2 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 3 | 3 |
| LPM | Lenses, Soft Contact, Extended Wear | 2 | 0 |
Review panels
- Ophthalmic (5)
Most recent Lombart Lenses, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971647 | LL BI-FOCAL, DAILY WEAR CONTACT LENS | LPL | 1997-07-15 | 71 |
| K961428 | SOFT-55 DAILY WEAR CONTACT LENS | LPL | 1996-05-21 | 36 |
| K941877 | LL-55 (METHAFILCON A) FOR DAILY WEAR | LPL | 1994-06-14 | 57 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890049 | PMA | FINISHED METHAFILCON A CONTACT LENSES | 1989-09-28 |
| P840031 | PMA | SAULFON PW-70 A&B | 1985-04-12 |
Recalls
openFDA lists no recalls under a recalling firm named Lombart Lenses, Ltd..
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 Lombart Lenses, Ltd.?
FDA lists 3 510(k) clearances under the applicant name “Lombart Lenses, Ltd.” (first 1994, latest 1997), plus 2 PMA decisions, across 2 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 Lombart Lenses, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lombart Lenses, Ltd. is 57 days.
Which FDA product codes appear under Lombart Lenses, Ltd.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 3); LPM (Lenses, Soft Contact, Extended Wear, 2).
Next steps
- See all 3 Lombart Lenses, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Lombart Lenses, Ltd.'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.