The Lagado Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “The Lagado Corp.” (first 2004, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 175 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 | 2 | 242 |
| 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 |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 3 | 3 |
| LPL | Lenses, Soft Contact, Daily Wear | 1 | 1 |
| LRX | Case, Contact Lens | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent The Lagado Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120756 | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE | LPL | 2013-05-13 | 426 |
| K130285 | PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS | LRX | 2013-04-03 | 57 |
| K102154 | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | 2011-01-21 | 175 |
| K052507 | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR | HQD | 2005-11-02 | 50 |
| K033599 | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | 2004-09-16 | 307 |
Recalls
openFDA lists no recalls under a recalling firm named The Lagado Corp..
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 The Lagado Corp.?
FDA lists 5 510(k) clearances under the applicant name “The Lagado Corp.” (first 2004, latest 2013), 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 The Lagado Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Lagado Corp. is 175 days.
Which FDA product codes appear under The Lagado Corp.?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 3); LPL (Lenses, Soft Contact, Daily Wear, 1); LRX (Case, Contact Lens, 1).
Next steps
- See all 5 The Lagado Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQD, The Lagado Corp.'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.