Data / Medical devices / United Kingdom / Coopervision Manufacturing, Ltd.
Coopervision Manufacturing, Ltd.: FDA-registered device maker in SOUTHAMPTON Hampshire, United Kingdom, 8 510(k) clearances and 1 PMA approval
Coopervision Manufacturing, Ltd. is registered with the FDA (registration 9614392) in SOUTHAMPTON Hampshire, United Kingdom. It lists 3 device types. The FDA files 8 510(k) clearances and 1 PMA approval under its listings, the newest dated February 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614392
- FEI number
- 3002806417
- Address
- Southpoint, Hamble Unit 2, SOUTHAMPTON Hampshire, United Kingdom, SO31 4RF
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- Avaira Vitality Sphere, Avaira Vitality Toric, BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 4, 2022 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 26, 2021 | K213164 | Avaira Vitality | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 20, 2020 | 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 | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| April 29, 2019 | K190965 | MyDay | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 5, 2013 | K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 19, 2008 | P080011 | BIOFINITY (COMFILCON A) | LPM | 201 | September 2, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Extended Wear
Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.