Alcon Research, Ltd. Dba Alcon Laboratories, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Alcon Research, Ltd. Dba Alcon Laboratories, Inc.” (first 2014, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 118 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 |
|---|---|---|
| 2014 | 1 | 118 |
| 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 |
|---|---|---|---|
| LZS | Excimer Laser System | 1 | 0 |
| OOE | Ophthalmic Femtosecond Laser | 1 | 1 |
Review panels
- Ophthalmic (2)
Most recent Alcon Research, Ltd. Dba Alcon Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141476 | WAVELIGHT FS200 LASER SYSTEM | OOE | 2014-09-30 | 118 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P910067 | PMA | EXCIMED(TM) UV200LA LASER SYSTEM | 1995-03-10 |
Recalls
11 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-04-30.
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 Universal, Ltd. (5 510(k)s)
- Alcon Surgical, Inc. (3 510(k)s)
- Alcon Lensx, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcon Research, Ltd. Dba Alcon Laboratories, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Alcon Research, Ltd. Dba Alcon Laboratories, Inc.” (first 2014, latest 2014), plus 1 PMA decision, 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 Research, Ltd. Dba Alcon Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon Research, Ltd. Dba Alcon Laboratories, Inc. is 118 days.
Which FDA product codes appear under Alcon Research, Ltd. Dba Alcon Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are LZS (Excimer Laser System, 1); OOE (Ophthalmic Femtosecond Laser, 1).
Next steps
- See all 1 Alcon Research, Ltd. Dba Alcon Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZS, Alcon Research, Ltd. Dba Alcon Laboratories, 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, 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.