Alcon Universal, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Alcon Universal, Ltd.” (first 2000, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 81 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Alcon, based on public ownership records.
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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | 3 | 3 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 2 | 2 |
Review panels
- Ophthalmic (5)
Most recent Alcon Universal, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021143 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | LPN | 2002-08-08 | 121 |
| K002589 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | LPN | 2000-10-23 | 63 |
| K001214 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | LPN | 2000-07-10 | 87 |
| K001235 | OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 | MRC | 2000-07-03 | 77 |
| K000385 | OPTI-FREE EXPRESS LENS DROPS | MRC | 2000-04-28 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Alcon Universal, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alcon Laboratories (90 510(k)s)
- Alcon Research, Ltd. (17 510(k)s)
- Alcon Manufacturing, Ltd. (6 510(k)s)
- Alcon (5 510(k)s)
- Alcon Surgical, Inc. (3 510(k)s)
- Alcon Lensx, Inc. (2 510(k)s)
- Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcon Universal, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Alcon Universal, Ltd.” (first 2000, latest 2002), 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 Alcon Universal, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon Universal, Ltd. is 81 days.
Which FDA product codes appear under Alcon Universal, Ltd.?
The most frequent FDA product codes under this applicant name are LPN (Accessories, Soft Lens Products, 3); MRC (Products, Contact Lens Care, Rigid Gas Permeable, 2).
Next steps
- See all 5 Alcon Universal, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPN, Alcon Universal, 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.