# CooperVision, Inc.

- Location (FDA's records): Southampton, GB
- FDA decisions: 106 (1976–2024): 97 510(k) clearances and 9 original PMA approvals
- Product codes: LPL (37), HQC (15), HQE (7), LPM (6), IYO (3), HQF (3), HKX (2), MVN (2), KYB (2), HPX (2), NUU (1), MWL (1)
- 510(k) review time since 2016: median 29 days, against 122 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 57 (27 its own); citations of its devices by later devices: 75 (27 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aspect Vision Care, Ltd.: 6 (https://510kreport.com/company/aspect-vision-care)
- Biocompatibles Eyewear, Inc.: 5 (https://510kreport.com/company/biocompatibles-eyewear)
- Biocompatibles, Inc.: 3 (https://510kreport.com/company/biocompatibles)
- Ocular Sciences: 3 (https://510kreport.com/company/ocular-sciences)
- Sauflon Pharmaceuticals, Ltd.: 3 (https://510kreport.com/company/sauflon-pharmaceuticals)
- Ciba Vision Corporation: 3 (https://510kreport.com/company/ciba-vision)
- Ocular Sciences Puerto Rico, Inc.: 2 (https://510kreport.com/company/ocular-sciences-puerto-rico)
- Cl-Tinters: 2 (https://510kreport.com/company/cl-tinters)

## Firms that cite its devices most
- Synergeyes, Inc.: 4 (https://510kreport.com/company/synergeyes)
- Vizionfocus, Inc.: 4 (https://510kreport.com/company/vizionfocus)
- Alcon Laboratories: 4 (https://510kreport.com/company/alcon-laboratories)
- Supervision Optimax Sdn Bhd: 3 (https://510kreport.com/company/supervision-optimax-sdn-bhd)
- Largan Medical Co., Ltd.: 3 (https://510kreport.com/company/largan-medical)
- Visco Vision, Inc.: 2 (https://510kreport.com/company/visco-vision)
- Pegavision Corporation: 2 (https://510kreport.com/company/pegavision)
- Gelflex Laboratories: 1 (https://510kreport.com/company/gelflex-laboratories)

## Its most-cited devices
- K052560: Biofinity (Comfilcon a) Soft Contact Lens (2005), cited by 15
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens (2006), cited by 5
- P870024: Fluoroperm RGP Contact Lenses (1987), cited by 4
- K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens (2008), cited by 4
- K131378: Sus (Stenfilcon a) Contact Lens (2013), cited by 4
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses (2011), cited by 4

## Recent decisions
- K234127: Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (Jan 25, 2024)
- K220070: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (Feb 4, 2022)
- K213164: Avaira Vitality (Oct 26, 2021)
- 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) (Oct 20, 2020)
- K191763: MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC (Mar 23, 2020)
- P180035: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (Nov 15, 2019)
- K190965: MyDay (Apr 29, 2019)
- K181920: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (Dec 11, 2018)

Source page: https://510kreport.com/company/coopervision