Alcon Research, Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Alcon Research, Ltd.” (first 2000, latest 2017), plus 5 PMA decisions, across 15 product codes in 2 review panels. Median 510(k) review time under this name: 132 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 | 2 | 125 |
| 2013 | 0 | — |
| 2014 | 1 | 120 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 158 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 158 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 | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| LPN | Accessories, Soft Lens Products | 2 | 2 |
| MLZ | Vitrectomy, Instrument Cutter | 2 | 2 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 2 | 2 |
| HNN | Knife, Ophthalmic | 1 | 1 |
| HQB | Photocoagulator And Accessories | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| HQL | Intraocular Lens | 1 | 0 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Alcon Research, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 |
| K093305 | ENHANCED ULTRA VIT PROBE | MLZ | 2010-04-02 | 162 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150037 | PMA | CyPass Micro-Stent | 2016-07-29 |
| P040020 | PMA | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL | 2005-03-21 |
| N13787 | PMA | ENUCLENE CLEANING/LUBRICATING SOLUTION | 1997-03-26 |
| P890047 | PMA | PROVISC(TM)VISCOELASTIC PREPARATION | 1991-09-26 |
| P830040 | PMA | STYLES 30 & 31 POSTERIOR CHAMBER IOLS | 1985-09-05 |
Recalls
44 product recalls in 32 recall events; 6 initiated in the last five years. Most recent: 2023-06-28.
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 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, 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 Research, Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Alcon Research, Ltd.” (first 2000, latest 2017), plus 5 PMA decisions, across 15 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 132 days.
Which FDA product codes appear under Alcon Research, Ltd.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 3); GEX (Powered Laser Surgical Instrument, 2); LPN (Accessories, Soft Lens Products, 2).
Next steps
- See all 16 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 (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.