Alcon Laboratories: FDA filings under this applicant name
FDA lists 90 510(k) clearances under the applicant name “Alcon Laboratories” (first 1976, latest 2026), plus 26 PMA decisions, across 41 product codes in 4 review panels. Median 510(k) review time under this name: 64 days. Since 2017 the median was 45 days, against 107 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 | 1 | 210 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 161 |
| 2016 | 7 | 30 |
| 2017 | 4 | 40 |
| 2018 | 6 | 56 |
| 2019 | 4 | 32 |
| 2020 | 2 | 28 |
| 2021 | 3 | 59 |
| 2022 | 1 | 28 |
| 2023 | 3 | 29 |
| 2024 | 3 | 132 |
| 2025 | 3 | 30 |
| 2026 | 1 | 58 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alcon Laboratories took a median 45 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 22 | 22 |
| LPN | Accessories, Soft Lens Products | 17 | 15 |
| HQC | Unit, Phacofragmentation | 8 | 8 |
| HQL | Intraocular Lens | 7 | 0 |
| LPM | Lenses, Soft Contact, Extended Wear | 6 | 0 |
| OOE | Ophthalmic Femtosecond Laser | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| LRX | Case, Contact Lens | 4 | 4 |
| LZS | Excimer Laser System | 4 | 0 |
| KYB | Lens, Guide, Intraocular | 3 | 3 |
Plus 31 more product codes.
Review panels
- Ophthalmic (100)
- General and Plastic Surgery (12)
- General Hospital (2)
- Gastroenterology and Urology (1)
Most recent Alcon Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | LPL | 2026-02-13 | 58 |
| K252682 | LenSx Laser System (8065000944) | OOE | 2025-09-24 | 30 |
| K243896 | LenSx Laser System (8065998162) | OOE | 2025-04-28 | 131 |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | LPL | 2025-01-13 | 25 |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | MPA | 2024-12-04 | 132 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | HQC | 2024-06-21 | 197 |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | HQC | 2024-01-10 | 30 |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | LPL | 2023-12-29 | 24 |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | LPL | 2023-11-16 | 58 |
| K230785 | Precision1, Precision1 for Astigmatism | LPL | 2023-04-20 | 29 |
80 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220007 | PMA | Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta | 2023-04-25 |
| P190018 | PMA | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | 2020-01-07 |
| P030008 | PMA | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM | 2003-10-10 |
| P020050 | PMA | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM | 2003-10-07 |
| P000030 | PMA | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES | 2001-10-12 |
Recalls
16 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2009-04-29.
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 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)
- Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcon Laboratories?
FDA lists 90 510(k) clearances under the applicant name “Alcon Laboratories” (first 1976, latest 2026), plus 26 PMA decisions, across 41 product codes in 4 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 Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcon Laboratories is 64 days. Since 2017: 45 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alcon Laboratories?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 22); LPN (Accessories, Soft Lens Products, 17); HQC (Unit, Phacofragmentation, 8).
Next steps
- See all 90 Alcon Laboratories clearances with predicates and recalls
- Run predicate analysis for product code LPL, Alcon Laboratories'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.