Alcon Research, Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Alcon Research, Ltd.” (first 2000, latest 2019), plus 8 PMA decisions, across 16 product codes in 2 review panels. Median 510(k) review time under this name: 134 days. Since 2017 the median was 134 days, against 91 days for all cleared 510(k)s in the same product codes. 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 | 2 | 125 |
| 2013 | 0 | — |
| 2014 | 1 | 120 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 158 |
| 2018 | 0 | — |
| 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, Ltd. 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 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| LPN | Accessories, Soft Lens Products | 2 | 2 |
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | 2 | 0 |
| MLZ | Vitrectomy, Instrument Cutter | 2 | 2 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 2 | 2 |
| OGO | Intraocular Pressure Lowering Implant | 2 | 0 |
| HNN | Knife, Ophthalmic | 1 | 1 |
| HQB | Photocoagulator And Accessories | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Alcon Research, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191650 | LEGION System | HQC | 2019-11-01 | 134 |
| K161794 | CENTURION Vision System (Active SentryTM) | HQC | 2017-04-14 | 288 |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | MLZ | 2017-03-22 | 28 |
| K141065 | CONSTELLATION VISION SYSTEM | HQE | 2014-08-22 | 120 |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | GEX | 2012-06-21 | 77 |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | MSS | 2012-03-27 | 173 |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | HQB | 2011-10-17 | 196 |
| K110166 | CLEARCUT S SAFETY KNIFE | HNN | 2011-05-20 | 120 |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | LPN | 2011-05-10 | 222 |
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | GEX | 2010-10-21 | 192 |
7 earlier clearances. See the full list in Caduvo.
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 |
| P150037 | PMA | CyPass Micro-Stent | 2016-07-29 |
| P040020 | PMA | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL | 2005-03-21 |
Recalls
111 product recalls in 55 recall events; 69 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.
Device clinical trials
An industry sponsor named Alcon Research, Ltd. is the lead sponsor of 266 device studies on ClinicalTrials.gov (9 active or recruiting). Most recent:
- NCT07228091: Surgical Procedure Efficiency Evaluation stuDy (Recruiting, started 2026-02-09)
- NCT07147192: Feasibility Study of an Accommodating IOL Design (Recruiting, started 2025-12-03)
- NCT07161635: Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs (Active not recruiting, started 2025-10-14)
- NCT07036835: Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation (Active not recruiting, started 2025-08-27)
- NCT06987474: Capella Scientia Development Study (Recruiting, started 2025-07-30)
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 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)
- Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcon Research, Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Alcon Research, Ltd.” (first 2000, latest 2019), plus 8 PMA decisions, across 16 product codes in 2 review panels. 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.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon Research, Ltd. is 134 days. Since 2017: 134 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alcon Research, Ltd.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 4); GEX (Powered Laser Surgical Instrument, 2); LPN (Accessories, Soft Lens Products, 2).
Next steps
- See all 17 Alcon Research, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Alcon Research, 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.