Alcon Manufacturing, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Alcon Manufacturing, Ltd.” (first 2007, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 152 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 | 1 | 81 |
| 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 4 | 4 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Alcon Manufacturing, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120912 | INFINITI(R) VISION SYSTEM | HQC | 2012-06-15 | 81 |
| K112425 | INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE | HQC | 2011-11-21 | 90 |
| K101774 | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) | MSS | 2011-10-13 | 476 |
| K101285 | CONSTELLATION VISION SYSTEM | HQC | 2010-11-12 | 189 |
| K093210 | AQUALASE CAPSULE WASH TIP | HQC | 2010-03-04 | 142 |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | KYB | 2007-03-27 | 161 |
Recalls
openFDA lists no recalls under a recalling firm named Alcon Manufacturing, 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 (5 510(k)s)
- Alcon Universal, Ltd. (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 Manufacturing, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Alcon Manufacturing, Ltd.” (first 2007, latest 2012), 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 Alcon Manufacturing, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon Manufacturing, Ltd. is 152 days.
Which FDA product codes appear under Alcon Manufacturing, Ltd.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 4); KYB (Lens, Guide, Intraocular, 1); MSS (Folders And Injectors, Intraocular Lens (Iol), 1).
Next steps
- See all 6 Alcon Manufacturing, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Alcon Manufacturing, 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.