Alcon Research, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Alcon Research, LLC” (first 2019, latest 2019), plus 3 PMA decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 134 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 |
|---|---|---|
| 2019 | 1 | 134 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alcon Research, LLC took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | 2 | 0 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| OGO | Intraocular Pressure Lowering Implant | 1 | 0 |
Review panels
- Ophthalmic (4)
Most recent Alcon Research, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191650 | LEGION System | HQC | 2019-11-01 | 134 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230012 | PMA | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | 2024-08-26 |
| P220030 | PMA | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | 2024-07-02 |
| P170034 | PMA | HYDRUS MICROSTENT | 2018-08-10 |
Recalls
67 product recalls in 23 recall events; 63 initiated in the last five years. Most recent: 2025-11-24.
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. (16 510(k)s)
- Alcon Manufacturing, Ltd. (6 510(k)s)
- Alcon, Inc. (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)
- Alcon Laboratories, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcon Research, LLC?
FDA lists 1 510(k) clearance under the applicant name “Alcon Research, LLC” (first 2019, latest 2019), plus 3 PMA decisions, 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 Research, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon Research, LLC is 134 days.
Which FDA product codes appear under Alcon Research, LLC?
The most frequent FDA product codes under this applicant name are LPO (Gases Used Within Eye To Place Pressure On Detached Retina, 2); HQC (Unit, Phacofragmentation, 1); OGO (Intraocular Pressure Lowering Implant, 1).
Next steps
- See all 1 Alcon Research, LLC clearances with predicates and recalls
- Run predicate analysis for product code LPO, Alcon Research, LLC'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.