Alcon, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Alcon, Inc.” (first 1998, latest 2008), plus 4 PMA decisions, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 162 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 |
|---|---|---|---|
| HQL | Intraocular Lens | 3 | 0 |
| LPN | Accessories, Soft Lens Products | 3 | 3 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| LWL | Fluid, Intraocular | 1 | 0 |
| LZU | Plug, Punctum | 1 | 1 |
Review panels
- Ophthalmic (9)
Most recent Alcon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063583 | ALCON VISION SYSTEM | HQC | 2008-05-09 | 526 |
| K071236 | ALCON MULTI-PURPOSE SOLUTION | LPN | 2007-12-12 | 223 |
| K040231 | INTELIPORT OCCLUDING DEVICE | LZU | 2004-07-13 | 162 |
| K031193 | SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION | LPN | 2003-07-03 | 78 |
| K981574 | OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION | LPN | 1998-07-06 | 63 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P950008 | PMA | SILIKON 1000 | 1997-09-25 |
| P820035 | PMA | OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5) | 1986-02-28 |
| P800049 | PMA | MODELS 1S & 1P | 1983-03-31 |
| P810001 | PMA | MODEL AC (AC1-AC5) | 1983-03-17 |
Recalls
openFDA lists no recalls under a recalling firm named Alcon, Inc..
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.
SEC filings
ALCON INC (ALC): EDGAR filings, CIK 1167379. An SEC registrant with the same name, matched by name only.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Alcon (6)
- Alcon, Inc. (3)
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. (16 510(k)s)
- Alcon Manufacturing, Ltd. (6 510(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, LLC (1 510(k)s)
- Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (1 510(k)s)
- Alcon Laboratories, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcon, Inc.?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Alcon, Inc.” (first 1998, latest 2008), plus 4 PMA decisions, across 5 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon, Inc. is 162 days.
Which FDA product codes appear under Alcon, Inc.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 3); LPN (Accessories, Soft Lens Products, 3); HQC (Unit, Phacofragmentation, 1).
Next steps
- See all 5 Alcon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Alcon, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.