CooperVision, Inc.: FDA clearances and approvals
CooperVision, Inc. has 97 FDA 510(k) clearances (first 1978, latest 2024), plus 9 PMA decisions, across 34 product codes in 6 review panels. Median 510(k) review time: 72 days. Since 2017 its median was 28 days, against 100 days for all cleared 510(k)s in the same product codes. openFDA lists 39 product recalls by a recalling firm named CooperVision, Inc. It is the industry lead sponsor of 151 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 104 |
| 2013 | 3 | 108 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 112 |
| 2017 | 0 | — |
| 2018 | 1 | 146 |
| 2019 | 1 | 17 |
| 2020 | 2 | 148 |
| 2021 | 1 | 28 |
| 2022 | 1 | 25 |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, CooperVision, Inc.'s cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 37 | 37 |
| HQC | Unit, Phacofragmentation | 15 | 15 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 7 | 7 |
| LPM | Lenses, Soft Contact, Extended Wear | 6 | 0 |
| HQF | Laser, Ophthalmic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| HKX | Tonometer, Ac-Powered | 2 | 2 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 2 | 2 |
| KYB | Lens, Guide, Intraocular | 2 | 2 |
| MVN | Lens, Contact, (Disposable) | 2 | 2 |
Plus 24 more product codes.
Review panels
- Ophthalmic (90)
- General and Plastic Surgery (5)
- Radiology (3)
- General Hospital (2)
- Dental (1)
- Ear, Nose and Throat (1)
Most recent CooperVision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | LPL | 2024-01-25 | 28 |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | 2022-02-04 | 25 |
| K213164 | Avaira Vitality | LPL | 2021-10-26 | 28 |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | LPL | 2020-10-20 | 29 |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | LPL | 2020-03-23 | 266 |
| K190965 | MyDay | LPL | 2019-04-29 | 17 |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | 2018-12-11 | 146 |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | 2016-07-13 | 112 |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | LPL | 2013-12-23 | 27 |
| K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | 2013-08-30 | 108 |
87 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180035 | PMA | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | 2019-11-15 |
| P080011 | PMA | BIOFINITY (COMFILCON A) | 2008-11-19 |
| P050031 | PMA | PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY | 2006-11-16 |
| P870024 | PMA | FLUOROPERM RGP CONTACT LENSES | 1987-12-31 |
| P850079 | PMA | HYDRASOFT (METHAFILCON B) CONTACT LENS | 1986-01-31 |
Recalls
39 product recalls in 18 recall events; 13 initiated in the last five years. Most recent: 2026-08-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
CooperVision, Inc. is the industry lead sponsor of 151 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06817785: Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere (Completed, started 2025-01-24)
- NCT06758076: A Clinical Comparison of Two Soft Contact Lenses (C24-755) (Completed, started 2024-11-18)
- NCT06590441: Investigation of Wearing Compliance of Spectacles for Myopia Control (Completed, started 2024-09-30)
- NCT06609018: Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses (Completed, started 2024-08-01)
- NCT06611410: 1 Week Crossover Study Between Two Soft Contact Lenses (Completed, started 2024-06-05)
Frequently asked questions
How many FDA 510(k) clearances does CooperVision, Inc. have?
CooperVision, Inc. has 97 FDA 510(k) clearances (first 1978, latest 2024), plus 9 PMA decisions, across 34 product codes in 6 review panels.
How long does FDA take to clear CooperVision, Inc.'s 510(k)s?
The median time from FDA receipt to decision across CooperVision, Inc.'s cleared 510(k)s is 72 days. Since 2017: 28 days, versus 100 days for all cleared 510(k)s in the same product codes.
What devices does CooperVision, Inc. make?
Its most frequent FDA product codes are LPL (Lenses, Soft Contact, Daily Wear, 37); HQC (Unit, Phacofragmentation, 15); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 7).
Has CooperVision, Inc. had device recalls?
openFDA lists 39 product recalls in 18 recall events by a recalling firm whose name matches CooperVision, Inc; the most recent began 2026-08-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 97 CooperVision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, CooperVision, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.